Promethazine Oral Tablet

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Sandoz Inc (2014-04-07)
Oldest Current Product
1973-09-19
License(s)
ANDA
RxNORM
ORAL TABLET\PROMETHAZINE
FDAOB
ORAL\TABLET\PROMETHAZINE HYDROCHLORIDE
SPL Active
ORAL\TABLET\PROMETHAZINE HYDROCHLORIDE
SPL Moiety
ORAL\TABLET\PROMETHAZINE

product(s) by strength(s)

promethazine hydrochloride 12.5 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001151040ANDAGlobal Pharmaceuticals2008-02-12PROMETHAZINE HYDROCHLORIDEORALTABLETANDA0407245af67c79-cd14-4873-8d6f-39453b439aad
2006035437ANDAQualitest Pharmaceuticals2006-07-18PROMETHAZINE HYDROCHLORIDEORALTABLETANDA040622d3b5ca09-9a02-45bf-a18c-1250ba9be309
3107020002ANDAKvk-Tech, Inc.2014-07-09PROMETHAZINE HYDROCHLORIDEORALTABLETANDA0407127a137adf-39b7-4b14-80da-c3cac9ad562a
4576640107ANDACaraco Pharmaceutical Laboratories, Ltd.2009-01-27PROMETHAZINE HYDROCHLORIDEORALTABLETANDA040863cb5950f9-dc5a-4a30-9f3e-08b006f27dd5
5651620745ANDAAmneal Pharmaceuticals2011-03-03PROMETHAZINE HYDROCHLORIDEORALTABLETANDA09117905907a49-537f-4bf2-8a5f-5e905f19fece
6658410040ANDACadila Healthcare Limited2005-12-14PROMETHAZINE HYDROCHLORIDEORALTABLETANDA0405964eaa8291-9cde-4205-857b-925ea8d618ba
7680010161ANDABluepoint Laboratories2014-01-13PROMETHAZINE HYDROCHLORIDEORALTABLETANDA04059644cd6d46-fbb9-4836-9426-d8ce2cb6d66d
8683820040ANDAZydus Pharmaceuticals (Usa) Inc.2005-12-14PROMETHAZINE HYDROCHLORIDEORALTABLETANDA040596c0c0d4f0-8396-485b-a585-71df01491f6f

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1006151539ANDANcs Healthcare Of Ky, Inc Dba Vangard Labs2005-12-14PROMETHAZINE HYDROCHLORIDEORALTABLET683820040ANDA0405968a45cdf8-f569-4ce1-9aa2-13923561fced
2105440051ANDABlenheim Pharmacal, Inc.2011-08-25PROMETHAZINE HYDROCHLORIDEORALTABLET107020003ANDA0407120f60819b-0014-42fb-e054-00144ff88e88
3105440512ANDABlenheim Pharmacal, Inc.2010-03-30PROMETHAZINE HYDROCHLORIDEORALTABLET683820040ANDA040596d989599c-7691-4157-ada4-c15d29d9112f
4165900047ANDAStat Rx Usa Llc2006-07-18PROMETHAZINE HYDROCHLORIDEORALTABLET006035437ANDA04062233d6acff-2858-46b2-bb9d-37b520ff015a
5216950589ANDARebel Distributors Corp2005-12-14PROMETHAZINE HYDROCHLORIDEORALTABLET683820040ANDA04059665b2f396-666b-4b08-890f-19429844e74b
6332610865ANDAAidarex Pharmaceuticals Llc2012-07-17PROMETHAZINE HYDROCHLORIDEORALTABLET107020002ANDA040712857dd0a8-3e23-423c-9b5e-9a8779b4c7d0
7516550112ANDANorthwind Pharmaceuticals, Llc2014-03-03PROMETHAZINE HYDROCHLORIDEORALTABLET683820040ANDA0405961ea20a7e-ebf1-4ba3-a7dd-61e0483e3b23
8548685121ANDAPhysicians Total Care, Inc.2005-05-23PROMETHAZINE HYDROCHLORIDEORALTABLET576640107ANDA040863ff1dddab-72a0-4125-859e-554bece2d2b3
9581180107ANDAClinical Solutions Wholesale2009-01-27PROMETHAZINE HYDROCHLORIDEORALTABLET576640107ANDA040863b8231a0f-28d8-40bd-add9-1d7e153ed11e
10604290149ANDAGolden State Medical Supply, Inc.2006-07-31PROMETHAZINE HYDROCHLORIDEORALTABLET107020002ANDA040712e849c26d-73a7-46ee-af42-e668e8d9b7bc
11619190047ANDADirect Rx2014-01-01PROMETHAZINE HYDROCHLORIDEORALTABLET651620745ANDA091179fcfed7b3-32f8-4fbc-ac41-79d7f45df5fc
12636291591ANDABryant Ranch Prepack2005-12-14PROMETHAZINE HYDROCHLORIDEORALTABLET683820040ANDA040596da246971-20b8-b46e-8366-9700d3604cf1
13642050745ANDAReadymeds2011-03-03PROMETHAZINE HYDROCHLORIDEORALTABLET651620745ANDA09117968b620fd-6d49-4a9b-8630-7fd38611fd53
14680840154ANDAAmerican Health Packaging2013-07-19PROMETHAZINE HYDROCHLORIDEORALTABLET683820040ANDA040596a8fe4bc5-961b-4441-b8e2-ef93e4e137b6
15687889762ANDAPreferred Pharmaceuticals, Inc.2015-08-19PROMETHAZINE HYDROCHLORIDEORALTABLET651620745ANDA091179521414ca-57f5-4855-a951-b99ac161b13f

promethazine hydrochloride 25 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001151041ANDAGlobal Pharmaceuticals2008-02-12PROMETHAZINE HYDROCHLORIDEORALTABLETANDA0407245af67c79-cd14-4873-8d6f-39453b439aad
2005915307ANDAWatson Laboratories, Inc.1973-09-19PROMETHAZINE HYDROCHLORIDEORALTABLETANDA083426a32255f0-0077-489e-bdc6-869aca8cd434
3006035438ANDAQualitest Pharmaceuticals2006-07-18PROMETHAZINE HYDROCHLORIDEORALTABLETANDA040622d3b5ca09-9a02-45bf-a18c-1250ba9be309
4007811830ANDASandoz Inc1975-12-19PROMETHAZINE HYDROCHLORIDEORALTABLETANDA08417624086b53-a85c-443e-ad85-c1295ddf23c7
5009045840ANDAMajor2008-05-09PROMETHAZINE HYDROCHLORIDEORALTABLETANDA0407124e9096f8-7c23-48a9-a5c3-75ada0f15f9d
6009046461ANDAMajor2015-03-15PROMETHAZINE HYDROCHLORIDEORALTABLETANDA0841763936f9fe-0bb8-447f-aa7f-1ddb0126f3ab
7107020003ANDAKvk-Tech, Inc.2014-07-09PROMETHAZINE HYDROCHLORIDEORALTABLETANDA0407127a137adf-39b7-4b14-80da-c3cac9ad562a
8576640108ANDACaraco Pharmaceutical Laboratories, Ltd.2009-01-27PROMETHAZINE HYDROCHLORIDEORALTABLETANDA040863cb5950f9-dc5a-4a30-9f3e-08b006f27dd5
9651620521ANDAAmneal Pharmaceuticals2011-03-03PROMETHAZINE HYDROCHLORIDEORALTABLETANDA09117905907a49-537f-4bf2-8a5f-5e905f19fece
10680010162ANDABluepoint Laboratories2014-01-13PROMETHAZINE HYDROCHLORIDEORALTABLETANDA04059644cd6d46-fbb9-4836-9426-d8ce2cb6d66d

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1521250162ANDARemedyrepack Inc.2013-03-25PROMETHAZINE HYDROCHLORIDEORALTABLET007811830ANDA0842349e8bb69b-7a58-49c6-bbce-e81348aecb36
2521250308ANDARemedyrepack Inc.2013-05-13PROMETHAZINE HYDROCHLORIDEORALTABLET007811830ANDA084234e027f9dc-da15-4929-8d04-fa931f5a6ef1
3551545423ANDACardinal Health2011-06-21PROMETHAZINE HYDROCHLORIDEORALTABLET007811830ANDA0842345436faa2-a6d8-4a24-ba3d-7614867d697d
4637390213ANDAMckesson Packaging Services A Business Unit Of Mckesson Corporation2008-08-24PROMETHAZINE HYDROCHLORIDEORALTABLET007811830ANDA084234818a4d9a-c8a2-476c-b70c-0840b6d603a1
5762370230ANDAMckesson Contract Packaging2011-09-14PROMETHAZINE HYDROCHLORIDEORALTABLET007811830ANDA0842340af133fc-a27d-4099-908a-0bdf7c64f22b

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1004408195ANDALiberty Pharmaceuticals, Inc.2012-07-17PROMETHAZINE HYDROCHLORIDEORALTABLET107020003ANDA04071296b4ab0d-abcf-409a-872e-b69611ebecca
2006157668ANDANcs Healthcare Of Ky, Inc Dba Vangard Labs2009-01-27PROMETHAZINE HYDROCHLORIDEORALTABLET576640108ANDA040863892fc7ea-be3d-4dfe-bfa0-2df97a6f03d9
3009046252ANDAMajor2011-07-14PROMETHAZINE HYDROCHLORIDEORALTABLET651620521ANDA0911798027df84-862f-4c21-96e2-fbca2c46f5e2
4105440618ANDABlenheim Pharmacal, Inc.2010-05-17PROMETHAZINE HYDROCHLORIDEORALTABLET005915307ANDA0834263cf7f19d-efbc-49eb-a4b6-cfbe45a7286e
5105440941ANDABlenheim Pharmacal, Inc.2015-09-01PROMETHAZINE HYDROCHLORIDEORALTABLET576640108ANDA0408631ec86d05-f8a6-684f-e054-00144ff88e88
6126340418ANDAApotheca, Inc1999-06-10PROMETHAZINE HYDROCHLORIDEORALTABLET651620521ANDA09117989d648db-dadc-436d-8a4d-d1637ea0e6a5
7165900191ANDAStat Rx Usa Llc1973-09-19PROMETHAZINE HYDROCHLORIDEORALTABLET005915307ANDA083426f83a009b-d6fe-4277-a522-daa8a6a27156
8216950453ANDARebel Distributors Corp1973-09-19PROMETHAZINE HYDROCHLORIDEORALTABLET005915307ANDA08342623a83c87-ad92-46af-aeed-12e93ab3255d
9242360110ANDARemedyrepack Inc.2012-08-28, 2012-12-21, 2013-04-08PROMETHAZINE HYDROCHLORIDEORALTABLET005915307ANDA08342603952eaf-41cb-447f-b1cf-698ecb2ae8ec, 5d65b5d3-0378-4f51-8a7e-8c88a190f0dd, 983f46b1-3710-416d-b8d1-56587296f26a
10332610131ANDAAidarex Pharmaceuticals Llc2012-07-17PROMETHAZINE HYDROCHLORIDEORALTABLET107020003ANDA040712857dd0a8-3e23-423c-9b5e-9a8779b4c7d0
11422540045ANDARebel Distributors Corp2011-03-03PROMETHAZINE HYDROCHLORIDEORALTABLET651620521ANDA091179749af379-2de0-4644-ae06-e8b03d863582
12425490543ANDAStat Rx Usa Llc1973-09-19PROMETHAZINE HYDROCHLORIDEORALTABLET005915307ANDA083426e23c09c2-47f5-47c1-825f-cbd8e3440058
13430630049ANDAPd-Rx Pharmaceuticals, Inc.2008-02-12PROMETHAZINE HYDROCHLORIDEORALTABLET001151041ANDA040724c222fb52-f1dd-4aa8-80be-b6bd91a04f89
14430630405ANDAPd-Rx Pharmaceuticals, Inc.2011-03-03PROMETHAZINE HYDROCHLORIDEORALTABLET651620521ANDA09117981fd29a9-c090-49ba-8b48-bd3656ca0c92
15499990090ANDALake Erie Medical Dba Quality Care Products Llc2010-10-28, 2010-11-24PROMETHAZINE HYDROCHLORIDEORALTABLET005915307ANDA08342679e401a6-30ae-47b6-8faf-85a54f1090ad, ff54560e-c905-4df4-b101-1f19a87af562
16504364379ANDAUnit Dose Services2012-07-17PROMETHAZINE HYDROCHLORIDEORALTABLET107020003ANDA040712cae114cf-6202-4960-8d48-b372b0a7dda7
17510790895ANDAMylan Institutional Inc.2007-02-01PROMETHAZINE HYDROCHLORIDEORALTABLET683820041ANDA04059650692fb9-2fde-4808-a8de-f1464a2896d8
18516550085ANDANorthwind Pharmaceuticals, Llc2014-06-01PROMETHAZINE HYDROCHLORIDEORALTABLET651620521ANDA091179ba4ec2d8-1da4-473b-9ef8-57051cb2c0f7
19516550114ANDANorthwind Pharmaceuticals, Llc2014-05-20PROMETHAZINE HYDROCHLORIDEORALTABLET683820041ANDA040596a5125d27-5258-41ec-b4aa-ca999d97a432
20516550588ANDANorthwind Pharmaceuticals, Llc2014-05-19PROMETHAZINE HYDROCHLORIDEORALTABLET683820041ANDA0405960a9b26e5-c31c-41a9-addd-9ce9a7878dc0
21521250566ANDARemedyrepack Inc.2013-05-23, 2014-02-26PROMETHAZINE HYDROCHLORIDEORALTABLET651620521ANDA091179637401ba-57bf-466d-b4dd-7b210b07e8f6, e06c9855-78c7-42f8-b8aa-d3f315675eb4
22521250639ANDARemedyrepack Inc.2013-05-30, 2013-10-29, 2013-12-05PROMETHAZINE HYDROCHLORIDEORALTABLET005915307ANDA08342682371c63-d69f-40c6-9c47-678176ffb35c, 8b7dea56-1782-481f-bbb7-1de873a145d0, cc3d5cec-5c7a-46cf-ac29-31ec25bdcddb
23521250703ANDARemedyrepack Inc.2013-09-19, 2013-12-31, 2014-10-28, 2014-11-24PROMETHAZINE HYDROCHLORIDEORALTABLET651620521ANDA09117944a17362-ed50-4c82-92e8-a33d678bb964, 7de2c1f4-587a-49ef-965a-c62e969c69ff, 93bb4e3c-0388-4b8a-bd9d-130403219a86, cff5fbde-a441-4721-8eff-0ed2ed894099
24529590534ANDAH.J. Harkins Company, Inc.2005-12-14PROMETHAZINE HYDROCHLORIDEORALTABLET683820041ANDA04059601b3a05f-6002-4cf9-96ac-ff0eed8a196c
25538080545ANDAState Of Florida Doh Central Pharmacy2009-07-01PROMETHAZINE HYDROCHLORIDEORALTABLET683820041ANDA04059673a5ab08-ce67-44c4-8f1c-43131578fda8
26538080546ANDAState Of Florida Doh Central Pharmacy2009-07-01PROMETHAZINE HYDROCHLORIDEORALTABLET107020003ANDA040712ba08126e-9354-406d-bf48-a1ad40900797
27545691754ANDAA-S Medication Solutions Llc2012-07-17PROMETHAZINE HYDROCHLORIDEORALTABLET107020003ANDA04071299e2e14a-8465-4635-820c-6cafbe5f3420
28545694168ANDAA-S Medication Solutions Llc2012-07-17PROMETHAZINE HYDROCHLORIDEORALTABLET107020003ANDA04071237b7b60e-20a2-410f-be6a-e7ec90d00bd3
29548681323ANDAPhysicians Total Care, Inc.1995-08-14PROMETHAZINE HYDROCHLORIDEORALTABLET576640108ANDA040863ff1dddab-72a0-4125-859e-554bece2d2b3
30551542535ANDACardinal Health2011-03-03PROMETHAZINE HYDROCHLORIDEORALTABLET651620521ANDA091179637c9ae1-30f4-470c-8cd4-5c577c499ade
31551544775ANDACardinal Health2006-09-08PROMETHAZINE HYDROCHLORIDEORALTABLET680840155ANDA040596b29ee375-0846-430c-8dc4-0315d1ac40aa
32551545697ANDACardinal Health2012-08-15PROMETHAZINE HYDROCHLORIDEORALTABLET510790895ANDA04059633cb25e1-4b45-4d2c-833f-912b8aca1ebe
33552890464ANDAPd-Rx Pharmaceuticals, Inc.2008-02-12PROMETHAZINE HYDROCHLORIDEORALTABLET001151041ANDA0407247687ec92-3c5c-4b3c-90cc-212b03658f75
34581185307ANDAClinical Solutions Wholesale1973-09-19PROMETHAZINE HYDROCHLORIDEORALTABLET005915307ANDA08342617f72b60-87e8-4d1e-b3f5-2f8a944f5478
35604290150ANDAGolden State Medical Supply, Inc.2006-07-31PROMETHAZINE HYDROCHLORIDEORALTABLET107020003ANDA040712e849c26d-73a7-46ee-af42-e668e8d9b7bc
36617860067ANDARemedyrepack Inc.2014-10-14PROMETHAZINE HYDROCHLORIDEORALTABLET009045840ANDA040712dbbc9ab7-9459-4ba8-99c2-307cc4257b60
37617860308ANDARemedyrepack Inc.2015-05-15PROMETHAZINE HYDROCHLORIDEORALTABLET576640108ANDA0408637684c4bf-0742-498a-8589-0ad3c6abf657
38619190008ANDADirect Rx2014-01-01PROMETHAZINE HYDROCHLORIDEORALTABLET651620521ANDA09117951e3baab-eba7-460c-9de1-bf6cfc378310
39619190191ANDADirect Rx2014-01-01PROMETHAZINE HYDROCHLORIDEORALTABLET005915307ANDA0834266d8bb5b0-9861-4570-aaa8-5918299f18d0
40631870038ANDAProficient Rx Lp2009-01-27PROMETHAZINE HYDROCHLORIDEORALTABLET576640108ANDA0408639910dd1f-297f-48e6-9a0a-30cd978bb90d
41636291742ANDABryant Ranch Prepack1973-09-19PROMETHAZINE HYDROCHLORIDEORALTABLET005915307ANDA083426850e3749-0af0-ce42-c683-5700a2804aa1
42642050521ANDAReadymeds2011-03-03PROMETHAZINE HYDROCHLORIDEORALTABLET651620521ANDA09117968b620fd-6d49-4a9b-8630-7fd38611fd53
43647250041ANDATya Pharmaceuticals2005-12-14PROMETHAZINE HYDROCHLORIDEORALTABLET683820041ANDA040596fe6294e3-2316-4efa-8be3-6e7e81158996
44647255307ANDATya Pharmaceuticals1973-09-19PROMETHAZINE HYDROCHLORIDEORALTABLET005915307ANDA083426225a440d-2c1d-47d6-9e31-bfbc06c35d47
45661160605ANDAMedvantx, Inc.2006-07-18PROMETHAZINE HYDROCHLORIDEORALTABLET006035438ANDA040622adb0c2bc-adc3-4f53-a3df-65c48c02d2e4
46663360085ANDADispensing Solutions, Inc.2006-07-18PROMETHAZINE HYDROCHLORIDEORALTABLET006035438ANDA04062268db2148-fd39-485e-86fc-f51813f32435
47680840155ANDAAmerican Health Packaging2013-07-19PROMETHAZINE HYDROCHLORIDEORALTABLET683820041ANDA040596a8fe4bc5-961b-4441-b8e2-ef93e4e137b6
48687889183ANDAPreferred Pharmaceuticals, Inc.1973-09-19PROMETHAZINE HYDROCHLORIDEORALTABLET005915307ANDA08342683169f64-42b9-43c2-b143-3282e7993a05
49687889270ANDAPreferred Pharmaceuticals, Inc.2014-01-02PROMETHAZINE HYDROCHLORIDEORALTABLET651620521ANDA09117901377b4c-e5be-41b7-877f-3102b40bda91
50687889679ANDAPreferred Pharmaceuticals, Inc.2013-04-24PROMETHAZINE HYDROCHLORIDEORALTABLET576640108ANDA040863b1a95331-12d0-42e8-bb46-ed12d3c212d5
51759210438ANDALife Line Home Care Services, Inc.2006-07-18PROMETHAZINE HYDROCHLORIDEORALTABLET006035438ANDA0406223c994fc1-824d-4a35-9be9-0554329ab3b5
52762370273ANDAMckesson Contract Packaging2012-02-02PROMETHAZINE HYDROCHLORIDEORALTABLET576640108ANDA040863097505e3-6abd-490d-89b9-334944c59b04

promethazine hydrochloride 50 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001151042ANDAGlobal Pharmaceuticals2008-05-20PROMETHAZINE HYDROCHLORIDEORALTABLETANDA0407915af67c79-cd14-4873-8d6f-39453b439aad
2005915319ANDAWatson Laboratories, Inc.1973-09-21PROMETHAZINE HYDROCHLORIDEORALTABLETANDA083711a32255f0-0077-489e-bdc6-869aca8cd434
3006035439ANDAQualitest Pharmaceuticals2006-07-18PROMETHAZINE HYDROCHLORIDEORALTABLETANDA040622d3b5ca09-9a02-45bf-a18c-1250ba9be309
4007811832ANDASandoz Inc1975-02-18PROMETHAZINE HYDROCHLORIDEORALTABLETANDA08417624086b53-a85c-443e-ad85-c1295ddf23c7
5107020004ANDAKvk-Tech, Inc.2014-07-09PROMETHAZINE HYDROCHLORIDEORALTABLETANDA0407127a137adf-39b7-4b14-80da-c3cac9ad562a
6576640109ANDACaraco Pharmaceutical Laboratories, Ltd.2009-01-27PROMETHAZINE HYDROCHLORIDEORALTABLETANDA040863cb5950f9-dc5a-4a30-9f3e-08b006f27dd5
7651620522ANDAAmneal Pharmaceuticals2011-03-03PROMETHAZINE HYDROCHLORIDEORALTABLETANDA09117905907a49-537f-4bf2-8a5f-5e905f19fece
8680010163ANDABluepoint Laboratories2014-01-13PROMETHAZINE HYDROCHLORIDEORALTABLETANDA04059644cd6d46-fbb9-4836-9426-d8ce2cb6d66d

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1216950885ANDARebel Distributors Corp2005-12-14PROMETHAZINE HYDROCHLORIDEORALTABLET683820042ANDA04059665b2f396-666b-4b08-890f-19429844e74b
2430630447ANDAPd-Rx Pharmaceuticals, Inc.2011-03-03PROMETHAZINE HYDROCHLORIDEORALTABLET651620522ANDA09117912400c65-f93b-47a5-8167-1fb14337130b
3548682844ANDAPhysicians Total Care, Inc.1997-03-26PROMETHAZINE HYDROCHLORIDEORALTABLET576640109ANDA040863ff1dddab-72a0-4125-859e-554bece2d2b3
4552890531ANDAPd-Rx Pharmaceuticals, Inc.2008-05-20PROMETHAZINE HYDROCHLORIDEORALTABLET001151042ANDA0407916685915c-1493-4382-8638-e922416d809f
5604290151ANDAGolden State Medical Supply, Inc.2006-07-31PROMETHAZINE HYDROCHLORIDEORALTABLET107020004ANDA040713e849c26d-73a7-46ee-af42-e668e8d9b7bc
6636295223ANDABryant Ranch Prepack2011-03-03PROMETHAZINE HYDROCHLORIDEORALTABLET651620522ANDA09117904eae982-1688-437c-8f17-58c2beb4e2d4
7637390389ANDAMckesson Packaging Services A Business Unit Of Mckesson Corporation2009-08-24PROMETHAZINE HYDROCHLORIDEORALTABLET007811832ANDA084176818a4d9a-c8a2-476c-b70c-0840b6d603a1

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA040558PROMETHAZINE HYDROCHLORIDETrueABLE LABORATORIES INC2004-07-01ANDA040558_001, ANDA040558_002, ANDA040558_003
2ANDA040596PROMETHAZINE HYDROCHLORIDEZYDUS PHARMACEUTICALS USA INC2005-11-18ANDA040596_001, ANDA040596_002, ANDA040596_003
3ANDA040622PROMETHAZINE HYDROCHLORIDEVINTAGE PHARMACEUTICALS INC2006-07-18ANDA040622_001, ANDA040622_002, ANDA040622_003
4ANDA040673PROMETHAZINE HYDROCHLORIDEHERITAGE PHARMA LABS INC2008-03-05ANDA040673_001, ANDA040673_002, ANDA040673_003
5ANDA040712PROMETHAZINE HYDROCHLORIDEKVK TECH INC2006-07-31ANDA040712_001, ANDA040712_002
6ANDA040713PROMETHAZINE HYDROCHLORIDEKVK TECH INC2006-07-31ANDA040713_001
7ANDA040724PROMETHAZINE HYDROCHLORIDEIMPAX LABORATORIES INC2008-02-12ANDA040724_001, ANDA040724_002
8ANDA040791PROMETHAZINE HYDROCHLORIDEIMPAX LABORATORIES INC2008-05-20ANDA040791_001
9ANDA040863PROMETHAZINE HYDROCHLORIDESUN PHARMACEUTICAL INDUSTRIES INC2008-12-30ANDA040863_001, ANDA040863_002, ANDA040863_003
10ANDA080949PROMETHAZINE HYDROCHLORIDETrueLANNETT CO INCANDA080949_001, ANDA080949_002, ANDA080949_003
11ANDA083176REMSEDTrueBRISTOL MYERS SQUIBB PHARMA COANDA083176_001, ANDA083176_002
12ANDA083204PROMETHAZINE HYDROCHLORIDETrueWATSON LABORATORIES INCANDA083204_001
13ANDA083214PROMETHAZINE HYDROCHLORIDETruePRIVATE FORMULATIONS INCANDA083214_001
14ANDA083401PROMETHAZINE HYDROCHLORIDETrueWATSON LABORATORIES INCANDA083401_001
15ANDA083403PROMETHAZINE HYDROCHLORIDETrueWATSON LABORATORIES INCANDA083403_001
16ANDA083426PROMETHAZINE HYDROCHLORIDEWATSON LABORATORIES INCANDA083426_001
17ANDA083603PROMETHAZINE HYDROCHLORIDETrueIVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USAANDA083603_001
18ANDA083604PROMETHAZINE HYDROCHLORIDETrueIVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USAANDA083604_001
19ANDA083613PROMETHAZINE HYDROCHLORIDETrueIVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USAANDA083613_001
20ANDA083658PROMETHAZINE HYDROCHLORIDETruePRIVATE FORMULATIONS INCANDA083658_001
21ANDA083711PROMETHAZINE HYDROCHLORIDEWATSON LABORATORIES INCANDA083711_001
22ANDA083712PROMETHAZINE HYDROCHLORIDETrueWATSON LABORATORIES INCANDA083712_001
23ANDA084027PROMETHAZINE HYDROCHLORIDETrueTABLICAPS INCANDA084027_001
24ANDA084080PROMETHAZINE HYDROCHLORIDETrueTABLICAPS INCANDA084080_001
25ANDA084160PROMETHAZINE HYDROCHLORIDETrueABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIVANDA084160_001
26ANDA084166PROMETHAZINE HYDROCHLORIDETrueABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIVANDA084166_001
27ANDA084176PROMETHAZINE HYDROCHLORIDESANDOZ INCANDA084176_001, ANDA084176_002, ANDA084176_003
28ANDA084214PROMETHAZINE HYDROCHLORIDETrueIMPAX LABORATORIES INC1982-07-07ANDA084214_002
29ANDA084233PROMETHAZINE HYDROCHLORIDETrueSANDOZ INCANDA084233_001
30ANDA084539PROMETHAZINE HYDROCHLORIDETrueABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIVANDA084539_001
31ANDA084554PROMETHAZINE HYDROCHLORIDETrueMUTUAL PHARMACEUTICAL CO INCANDA084554_001
32ANDA084555PROMETHAZINE HYDROCHLORIDETrueMUTUAL PHARMACEUTICAL CO INCANDA084555_001
33ANDA084557PROMETHAZINE HYDROCHLORIDETrueMUTUAL PHARMACEUTICAL CO INCANDA084557_001
34ANDA085146PROMETHAZINE HYDROCHLORIDETrueSANDOZ INCANDA085146_001, ANDA085146_002
35ANDA085664PROMETHAZINE HYDROCHLORIDETrueWATSON LABORATORIES INCANDA085664_001
36ANDA085684PROMETHAZINE HYDROCHLORIDETrueWATSON LABORATORIES INCANDA085684_001
37ANDA085986PROMETHAZINE HYDROCHLORIDETrueWATSON LABORATORIES INCANDA085986_001
38ANDA089109PROMETHAZINE HYDROCHLORIDETrueTEVA PHARMACEUTICALS USA INC1985-09-10ANDA089109_001
39ANDA091054PROMETHAZINE HYDROCHLORIDEMYLAN PHARMACEUTICALS INC2011-08-30ANDA091054_001, ANDA091054_002, ANDA091054_003
40ANDA091179PROMETHAZINE HYDROCHLORIDEAMNEAL PHARMACEUTICALS NY LLC2010-12-13ANDA091179_001, ANDA091179_002, ANDA091179_003
41NDA007935PHENERGANTrueDELCOR ASSET CORPNDA007935_002, NDA007935_003, NDA007935_004

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA040558_001discontinuedPROMETHAZINE HYDROCHLORIDE (12.5MG)ORALTABLETFalse2004-07-01PROMETHAZINE HYDROCHLORIDE
2ANDA040558_002discontinuedPROMETHAZINE HYDROCHLORIDE (25MG)ORALTABLETFalse2004-07-01PROMETHAZINE HYDROCHLORIDE
3ANDA040558_003discontinuedPROMETHAZINE HYDROCHLORIDE (50MG)ORALTABLETFalse2004-07-01PROMETHAZINE HYDROCHLORIDE
4ANDA040596_001RXPROMETHAZINE HYDROCHLORIDE (12.5MG)ORALTABLETFalseAB2005-11-18PROMETHAZINE HYDROCHLORIDE
5ANDA040596_002RXPROMETHAZINE HYDROCHLORIDE (25MG)ORALTABLETFalseAB2005-11-18PROMETHAZINE HYDROCHLORIDE
6ANDA040596_003RXPROMETHAZINE HYDROCHLORIDE (50MG)ORALTABLETFalseAB2005-11-18PROMETHAZINE HYDROCHLORIDE
7ANDA040622_001RXPROMETHAZINE HYDROCHLORIDE (12.5MG)ORALTABLETFalseAB2006-07-18PROMETHAZINE HYDROCHLORIDE
8ANDA040622_002RXPROMETHAZINE HYDROCHLORIDE (25MG)ORALTABLETFalseAB2006-07-18PROMETHAZINE HYDROCHLORIDE
9ANDA040622_003RXPROMETHAZINE HYDROCHLORIDE (50MG)ORALTABLETFalseAB2006-07-18PROMETHAZINE HYDROCHLORIDE
10ANDA040673_001RXPROMETHAZINE HYDROCHLORIDE (12.5MG)ORALTABLETFalseAB2008-03-05PROMETHAZINE HYDROCHLORIDE
11ANDA040673_002RXPROMETHAZINE HYDROCHLORIDE (25MG)ORALTABLETFalseAB2008-03-05PROMETHAZINE HYDROCHLORIDE
12ANDA040673_003RXPROMETHAZINE HYDROCHLORIDE (50MG)ORALTABLETFalseAB2008-03-05PROMETHAZINE HYDROCHLORIDE
13ANDA040712_001RXPROMETHAZINE HYDROCHLORIDE (25MG)ORALTABLETFalseAB2006-07-31PROMETHAZINE HYDROCHLORIDE
14ANDA040712_002RXPROMETHAZINE HYDROCHLORIDE (12.5MG)ORALTABLETFalseAB2007-05-04PROMETHAZINE HYDROCHLORIDE
15ANDA040713_001RXPROMETHAZINE HYDROCHLORIDE (50MG)ORALTABLETFalseAB2006-07-31PROMETHAZINE HYDROCHLORIDE
16ANDA040724_001RXPROMETHAZINE HYDROCHLORIDE (12.5MG)ORALTABLETFalseAB2008-02-12PROMETHAZINE HYDROCHLORIDE
17ANDA040724_002RXPROMETHAZINE HYDROCHLORIDE (25MG)ORALTABLETFalseAB2008-02-12PROMETHAZINE HYDROCHLORIDE
18ANDA040791_001RXPROMETHAZINE HYDROCHLORIDE (50MG)ORALTABLETFalseAB2008-05-20PROMETHAZINE HYDROCHLORIDE
19ANDA040863_001RXPROMETHAZINE HYDROCHLORIDE (12.5MG)ORALTABLETFalseAB2008-12-30PROMETHAZINE HYDROCHLORIDE
20ANDA040863_002RXPROMETHAZINE HYDROCHLORIDE (25MG)ORALTABLETFalseAB2008-12-30PROMETHAZINE HYDROCHLORIDE
21ANDA040863_003RXPROMETHAZINE HYDROCHLORIDE (50MG)ORALTABLETFalseAB2008-12-30PROMETHAZINE HYDROCHLORIDE
22ANDA080949_001discontinuedPROMETHAZINE HYDROCHLORIDE (12.5MG)ORALTABLETFalsePROMETHAZINE HYDROCHLORIDE
23ANDA080949_002discontinuedPROMETHAZINE HYDROCHLORIDE (25MG)ORALTABLETFalsePROMETHAZINE HYDROCHLORIDE
24ANDA080949_003discontinuedPROMETHAZINE HYDROCHLORIDE (50MG)ORALTABLETFalsePROMETHAZINE HYDROCHLORIDE
25ANDA083176_001discontinuedPROMETHAZINE HYDROCHLORIDE (50MG)ORALTABLETFalseREMSED
26ANDA083176_002discontinuedPROMETHAZINE HYDROCHLORIDE (25MG)ORALTABLETFalseREMSED
27ANDA083204_001discontinuedPROMETHAZINE HYDROCHLORIDE (25MG)ORALTABLETFalsePROMETHAZINE HYDROCHLORIDE
28ANDA083214_001discontinuedPROMETHAZINE HYDROCHLORIDE (12.5MG)ORALTABLETFalsePROMETHAZINE HYDROCHLORIDE
29ANDA083401_001discontinuedPROMETHAZINE HYDROCHLORIDE (12.5MG)ORALTABLETFalsePROMETHAZINE HYDROCHLORIDE
30ANDA083403_001discontinuedPROMETHAZINE HYDROCHLORIDE (50MG)ORALTABLETFalsePROMETHAZINE HYDROCHLORIDE
31ANDA083426_001RXPROMETHAZINE HYDROCHLORIDE (25MG)ORALTABLETFalseABPROMETHAZINE HYDROCHLORIDE
32ANDA083603_001discontinuedPROMETHAZINE HYDROCHLORIDE (25MG)ORALTABLETFalsePROMETHAZINE HYDROCHLORIDE
33ANDA083604_001discontinuedPROMETHAZINE HYDROCHLORIDE (12.5MG)ORALTABLETFalsePROMETHAZINE HYDROCHLORIDE
34ANDA083613_001discontinuedPROMETHAZINE HYDROCHLORIDE (50MG)ORALTABLETFalsePROMETHAZINE HYDROCHLORIDE
35ANDA083658_001discontinuedPROMETHAZINE HYDROCHLORIDE (25MG)ORALTABLETFalsePROMETHAZINE HYDROCHLORIDE
36ANDA083711_001RXPROMETHAZINE HYDROCHLORIDE (50MG)ORALTABLETFalseABPROMETHAZINE HYDROCHLORIDE
37ANDA083712_001discontinuedPROMETHAZINE HYDROCHLORIDE (12.5MG)ORALTABLETFalsePROMETHAZINE HYDROCHLORIDE
38ANDA084027_001discontinuedPROMETHAZINE HYDROCHLORIDE (25MG)ORALTABLETFalsePROMETHAZINE HYDROCHLORIDE
39ANDA084080_001discontinuedPROMETHAZINE HYDROCHLORIDE (12.5MG)ORALTABLETFalsePROMETHAZINE HYDROCHLORIDE
40ANDA084160_001discontinuedPROMETHAZINE HYDROCHLORIDE (12.5MG)ORALTABLETFalsePROMETHAZINE HYDROCHLORIDE
41ANDA084166_001discontinuedPROMETHAZINE HYDROCHLORIDE (25MG)ORALTABLETFalsePROMETHAZINE HYDROCHLORIDE
42ANDA084176_001RXPROMETHAZINE HYDROCHLORIDE (50MG)ORALTABLETTrueABPROMETHAZINE HYDROCHLORIDE
43ANDA084176_002discontinuedPROMETHAZINE HYDROCHLORIDE (12.5MG)ORALTABLETFalse2009-05-22PROMETHAZINE HYDROCHLORIDE
44ANDA084176_003RXPROMETHAZINE HYDROCHLORIDE (25MG)ORALTABLETFalseABPROMETHAZINE HYDROCHLORIDE
45ANDA084214_002discontinuedPROMETHAZINE HYDROCHLORIDE (25MG)ORALTABLETFalse1982-07-07PROMETHAZINE HYDROCHLORIDE
46ANDA084233_001discontinuedPROMETHAZINE HYDROCHLORIDE (12.5MG)ORALTABLETFalsePROMETHAZINE HYDROCHLORIDE
47ANDA084539_001discontinuedPROMETHAZINE HYDROCHLORIDE (50MG)ORALTABLETFalsePROMETHAZINE HYDROCHLORIDE
48ANDA084554_001discontinuedPROMETHAZINE HYDROCHLORIDE (25MG)ORALTABLETFalsePROMETHAZINE HYDROCHLORIDE
49ANDA084555_001discontinuedPROMETHAZINE HYDROCHLORIDE (12.5MG)ORALTABLETFalsePROMETHAZINE HYDROCHLORIDE
50ANDA084557_001discontinuedPROMETHAZINE HYDROCHLORIDE (50MG)ORALTABLETFalsePROMETHAZINE HYDROCHLORIDE
51ANDA085146_001discontinuedPROMETHAZINE HYDROCHLORIDE (25MG)ORALTABLETFalsePROMETHAZINE HYDROCHLORIDE
52ANDA085146_002discontinuedPROMETHAZINE HYDROCHLORIDE (50MG)ORALTABLETFalsePROMETHAZINE HYDROCHLORIDE
53ANDA085664_001discontinuedPROMETHAZINE HYDROCHLORIDE (50MG)ORALTABLETFalsePROMETHAZINE HYDROCHLORIDE
54ANDA085684_001discontinuedPROMETHAZINE HYDROCHLORIDE (25MG)ORALTABLETFalsePROMETHAZINE HYDROCHLORIDE
55ANDA085986_001discontinuedPROMETHAZINE HYDROCHLORIDE (12.5MG)ORALTABLETFalsePROMETHAZINE HYDROCHLORIDE
56ANDA089109_001discontinuedPROMETHAZINE HYDROCHLORIDE (25MG)ORALTABLETFalse1985-09-10PROMETHAZINE HYDROCHLORIDE
57ANDA091054_001RXPROMETHAZINE HYDROCHLORIDE (12.5MG)ORALTABLETFalseAB2011-08-30PROMETHAZINE HYDROCHLORIDE
58ANDA091054_002RXPROMETHAZINE HYDROCHLORIDE (25MG)ORALTABLETFalseAB2011-08-30PROMETHAZINE HYDROCHLORIDE
59ANDA091054_003RXPROMETHAZINE HYDROCHLORIDE (50MG)ORALTABLETFalseAB2011-08-30PROMETHAZINE HYDROCHLORIDE
60ANDA091179_001RXPROMETHAZINE HYDROCHLORIDE (12.5MG)ORALTABLETFalseAB2010-12-13PROMETHAZINE HYDROCHLORIDE
61ANDA091179_002RXPROMETHAZINE HYDROCHLORIDE (25MG)ORALTABLETFalseAB2010-12-13PROMETHAZINE HYDROCHLORIDE
62ANDA091179_003RXPROMETHAZINE HYDROCHLORIDE (50MG)ORALTABLETFalseAB2010-12-13PROMETHAZINE HYDROCHLORIDE
63NDA007935_002discontinuedPROMETHAZINE HYDROCHLORIDE (12.5MG)ORALTABLETFalsePHENERGAN
64NDA007935_003discontinuedPROMETHAZINE HYDROCHLORIDE (25MG)ORALTABLETFalsePHENERGAN
65NDA007935_004discontinuedPROMETHAZINE HYDROCHLORIDE (50MG)ORALTABLETFalsePHENERGAN

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
101377b4c-e5be-41b7-877f-3102b40bda91 (view SPL)PROMETHAZINE HYDROCHLORIDE TABLETS, USPprescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.REPACK2015-01-151687889270
201b3a05f-6002-4cf9-96ac-ff0eed8a196c (view SPL)Promethazine Hydrochloride Tablets USPprescriptionHuman PrescriptionH.J. Harkins Company, Inc.Analysis, Manufacture2012-04-182529590534
303952eaf-41cb-447f-b1cf-698ecb2ae8ec (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2012-08-281242360110
404eae982-1688-437c-8f17-58c2beb4e2d4 (view SPL)PROMETHAZINE HYDROCHLORIDE TABLETS, USPprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2014-05-151000636295223
505907a49-537f-4bf2-8a5f-5e905f19fece (view SPL)PROMETHAZINE HYDROCHLORIDE TABLETS, USPprescriptionHuman PrescriptionAmneal PharmaceuticalsANALYSIS, LABEL, MANUFACTURE, PACK2012-02-213651620521, 651620522, 651620745
6097505e3-6abd-490d-89b9-334944c59b04 (view SPL)prescriptionHuman PrescriptionMckesson Contract PackagingREPACK2012-02-271762370273
70a9b26e5-c31c-41a9-addd-9ce9a7878dc0 (view SPL)prescriptionHuman PrescriptionNorthwind Pharmaceuticals, Llcrepack2014-05-211516550588
80af133fc-a27d-4099-908a-0bdf7c64f22b (view SPL)Promethazine Hydrochloride Tablets, USPRx OnlyprescriptionHuman PrescriptionMckesson Contract PackagingREPACK2011-11-171762370230
90f60819b-0014-42fb-e054-00144ff88e88 (view SPL)PROMETHAZINE HYDROCHLORIDE TABLETS, USPprescriptionHuman PrescriptionBlenheim Pharmacal, Inc.repack2015-02-181105440051
1012400c65-f93b-47a5-8167-1fb14337130b (view SPL)PROMETHAZINE HYDROCHLORIDE TABLETS, USPprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2012-02-215430630447
1117f72b60-87e8-4d1e-b3f5-2f8a944f5478 (view SPL)Promethazine Hydrochloride Tablets USPprescriptionHuman PrescriptionClinical Solutions Wholesalerelabel, repack2013-05-281581185307
121ea20a7e-ebf1-4ba3-a7dd-61e0483e3b23 (view SPL)prescriptionHuman PrescriptionNorthwind Pharmaceuticals, Llcrepack2014-06-041516550112
131ec86d05-f8a6-684f-e054-00144ff88e88 (view SPL)prescriptionHuman PrescriptionBlenheim Pharmacal, Inc.repack2015-09-022105440941
14225a440d-2c1d-47d6-9e31-bfbc06c35d47 (view SPL)Promethazine Hydrochloride Tablets USP Revised: June 2009 Rx only 190824prescriptionHuman PrescriptionTya PharmaceuticalsRELABEL, REPACK2011-04-052647255307
1523a83c87-ad92-46af-aeed-12e93ab3255d (view SPL)Promethazine Hydrochloride Tablets USP Revised: January 2005 Rx onlyprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2010-11-111216950453
1624086b53-a85c-443e-ad85-c1295ddf23c7 (view SPL)Promethazine Hydrochloride Tablets, USPprescriptionHuman PrescriptionSandoz Inc2014-04-0714007811830, 007811832
1733cb25e1-4b45-4d2c-833f-912b8aca1ebe (view SPL)Promethazine Hydrochloride Tablets USPprescriptionHuman PrescriptionCardinal HealthREPACK2014-06-033551545697
1833d6acff-2858-46b2-bb9d-37b520ff015a (view SPL)PROMETHAZINE HYDROCHLORIDE TABLETS, USPprescriptionHuman PrescriptionStat Rx Usa Llcrelabel, repack2010-06-281165900047
1937b7b60e-20a2-410f-be6a-e7ec90d00bd3 (view SPL)prescriptionHuman PrescriptionA-S Medication Solutions Llcrepack2013-06-291545694168
203936f9fe-0bb8-447f-aa7f-1ddb0126f3ab (view SPL)Promethazine Hydrochloride Tablets, USPprescriptionHuman PrescriptionMajor2015-03-051009046461
213c994fc1-824d-4a35-9be9-0554329ab3b5 (view SPL)PROMETHAZINE HYDROCHLORIDE TABLETS, USPprescriptionHuman PrescriptionLife Line Home Care Services, Inc.relabel, repack2012-03-081759210438
223cf7f19d-efbc-49eb-a4b6-cfbe45a7286e (view SPL)Promethazine Hydrochloride Tablets USP Revised: June 2009 Rx only 190824prescriptionHuman PrescriptionBlenheim Pharmacal, Inc.repack2011-04-292105440618
2344a17362-ed50-4c82-92e8-a33d678bb964 (view SPL)PROMETHAZINE HYDROCHLORIDE TABLETS, USPprescriptionHuman PrescriptionRemedyrepack Inc.2013-12-311521250703
2444cd6d46-fbb9-4836-9426-d8ce2cb6d66d (view SPL)Promethazine Hydrochloride Tablets USPprescriptionHuman PrescriptionBluepoint LaboratoriesANALYSIS, MANUFACTURE2015-07-232680010161, 680010162, 680010163
254e9096f8-7c23-48a9-a5c3-75ada0f15f9d (view SPL)PROMETHAZINE HYDROCHLORIDETablets, USPprescriptionHuman PrescriptionMajor2012-07-202009045840
264eaa8291-9cde-4205-857b-925ea8d618ba (view SPL)Promethazine Hydrochloride Tablets USPprescriptionHuman PrescriptionCadila Healthcare LimitedAnalysis, Manufacture2011-05-061658410040
2750692fb9-2fde-4808-a8de-f1464a2896d8 (view SPL)Promethazine Hydrochloride Tablets USPprescriptionHuman PrescriptionMylan Institutional Inc.2014-01-032510790895
2851e3baab-eba7-460c-9de1-bf6cfc378310 (view SPL)PROMETHAZINE HYDROCHLORIDEprescriptionHuman PrescriptionDirect Rxrepack2015-06-253619190008
29521414ca-57f5-4855-a951-b99ac161b13f (view SPL)PROMETHAZINE HYDROCHLORIDE TABLETS, USPprescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.REPACK2015-08-191687889762
305436faa2-a6d8-4a24-ba3d-7614867d697d (view SPL)Promethazine Hydrochloride Tablets, USPprescriptionHuman PrescriptionCardinal HealthREPACK2013-08-131551545423
315af67c79-cd14-4873-8d6f-39453b439aad (view SPL)PROMETHAZINE HYDROCHLORIDE TABLETS, USPprescriptionHuman PrescriptionGlobal PharmaceuticalsREPACK2010-05-272001151040, 001151041, 001151042
325d65b5d3-0378-4f51-8a7e-8c88a190f0dd (view SPL)Promethazine Hydrochloride Tablets USP Revised: June 2009 Rx only 190824prescriptionHuman PrescriptionRemedyrepack Inc.2013-04-082242360110
33637401ba-57bf-466d-b4dd-7b210b07e8f6 (view SPL)PROMETHAZINE HYDROCHLORIDE TABLETS, USPprescriptionHuman PrescriptionRemedyrepack Inc.2013-05-231521250566
34637c9ae1-30f4-470c-8cd4-5c577c499ade (view SPL)PROMETHAZINE HYDROCHLORIDE TABLETS, USPprescriptionHuman PrescriptionCardinal HealthREPACK2014-04-244551542535
3565b2f396-666b-4b08-890f-19429844e74b (view SPL)Promethazine Hydrochloride Tablets USPprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2011-01-041216950589, 216950885
366685915c-1493-4382-8638-e922416d809f (view SPL)PROMETHAZINE HYDROCHLORIDE TABLETS, USPprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2010-05-272552890531
3768b620fd-6d49-4a9b-8630-7fd38611fd53 (view SPL)PROMETHAZINE HYDROCHLORIDE TABLETS, USPprescriptionHuman PrescriptionReadymedsrepack2014-05-064642050521, 642050745
3868db2148-fd39-485e-86fc-f51813f32435 (view SPL)PROMETHAZINE HYDROCHLORIDE TABLETS, USPprescriptionHuman PrescriptionDispensing Solutions, Inc.relabel, repack2013-07-172663360085
396d8bb5b0-9861-4570-aaa8-5918299f18d0 (view SPL)PROMETHAZINE HYDROCHLORIDEprescriptionHuman PrescriptionDirect Rxrelabel, repack2015-01-131619190191
4073a5ab08-ce67-44c4-8f1c-43131578fda8 (view SPL)Promethazine Hydrochloride Tablets USP Rx onlyprescriptionHuman PrescriptionState Of Florida Doh Central Pharmacyrepack2010-06-011538080545
41749af379-2de0-4644-ae06-e8b03d863582 (view SPL)PROMETHAZINE HYDROCHLORIDE TABLETS, USPprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2011-12-271422540045
427684c4bf-0742-498a-8589-0ad3c6abf657 (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2015-05-151617860308
437687ec92-3c5c-4b3c-90cc-212b03658f75 (view SPL)PROMETHAZINE HYDROCHLORIDE TABLETS, USPprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2010-05-273552890464
4479e401a6-30ae-47b6-8faf-85a54f1090ad (view SPL)Promethazine Hydrochloride 25 MGprescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcmanufacture, repack2011-12-283431499990090
457a137adf-39b7-4b14-80da-c3cac9ad562a (view SPL)PROMETHAZINE HYDROCHLORIDE TABLETS, USPprescriptionHuman PrescriptionKvk-Tech, Inc.MANUFACTURE2015-10-054107020002, 107020003, 107020004
467de2c1f4-587a-49ef-965a-c62e969c69ff (view SPL)PROMETHAZINE HYDROCHLORIDE TABLETS, USPprescriptionHuman PrescriptionRemedyrepack Inc.2014-11-242521250703
478027df84-862f-4c21-96e2-fbca2c46f5e2 (view SPL)PromethazineprescriptionHuman PrescriptionMajorRELABEL, REPACK2011-07-186009046252
48818a4d9a-c8a2-476c-b70c-0840b6d603a1 (view SPL)Promethazine Hydrochloride Tablets, USPprescriptionHuman PrescriptionMckesson Packaging Services A Business Unit Of Mckesson Corporationrepack2009-08-241637390213, 637390389
4981fd29a9-c090-49ba-8b48-bd3656ca0c92 (view SPL)PROMETHAZINE HYDROCHLORIDE TABLETS, USPprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2012-02-215430630405
5082371c63-d69f-40c6-9c47-678176ffb35c (view SPL)Promethazine Hydrochloride Tablets USP Revised: June 2009 Rx only 190824prescriptionHuman PrescriptionRemedyrepack Inc.2013-12-051521250639
5183169f64-42b9-43c2-b143-3282e7993a05 (view SPL)Promethazine Hydrochloride Tablets USPprescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.REPACK2015-01-154687889183
52850e3749-0af0-ce42-c683-5700a2804aa1 (view SPL)Promethazine Hydrochloride Tablets USPprescriptionHuman PrescriptionBryant Ranch PrepackMANUFACTURE, RELABEL, REPACK2012-10-122636291742
53857dd0a8-3e23-423c-9b5e-9a8779b4c7d0 (view SPL)Unknown TitleprescriptionHuman PrescriptionAidarex Pharmaceuticals Llc2014-03-288332610131, 332610865
54892fc7ea-be3d-4dfe-bfa0-2df97a6f03d9 (view SPL)Promethazine HydrochlorideprescriptionHuman PrescriptionNcs Healthcare Of Ky, Inc Dba Vangard LabsREPACK2015-04-078006157668
5589d648db-dadc-436d-8a4d-d1637ea0e6a5 (view SPL)PROMETHAZINE HYDROCHLORIDE TabletprescriptionHuman PrescriptionApotheca, Increpack2013-11-151126340418
568a45cdf8-f569-4ce1-9aa2-13923561fced (view SPL)Promethazine HCl Tablets, USPprescriptionHuman PrescriptionNcs Healthcare Of Ky, Inc Dba Vangard LabsRELABEL, REPACK2013-02-254006151539
578b7dea56-1782-481f-bbb7-1de873a145d0 (view SPL)Promethazine Hydrochloride Tablets USP Revised: June 2009 Rx only 190824prescriptionHuman PrescriptionRemedyrepack Inc.2013-05-301521250639
5893bb4e3c-0388-4b8a-bd9d-130403219a86 (view SPL)PROMETHAZINE HYDROCHLORIDE TABLETS, USPprescriptionHuman PrescriptionRemedyrepack Inc.2014-10-281521250703
5996b4ab0d-abcf-409a-872e-b69611ebecca (view SPL)Unknown TitleprescriptionHuman PrescriptionLiberty Pharmaceuticals, Inc.2013-09-111004408195
60983f46b1-3710-416d-b8d1-56587296f26a (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2012-12-211242360110
619910dd1f-297f-48e6-9a0a-30cd978bb90d (view SPL)prescriptionHuman PrescriptionProficient Rx LpRELABEL, REPACK2014-04-305631870038
6299e2e14a-8465-4635-820c-6cafbe5f3420 (view SPL)prescriptionHuman PrescriptionA-S Medication Solutions Llcrepack2013-06-291545691754
639e8bb69b-7a58-49c6-bbce-e81348aecb36 (view SPL)Promethazine Hydrochloride Tablets, USPprescriptionHuman PrescriptionRemedyrepack Inc.2013-03-251521250162
64a32255f0-0077-489e-bdc6-869aca8cd434 (view SPL)Promethazine Hydrochloride Tablets USP Revised: June 2009 Rx only 190824prescriptionHuman PrescriptionWatson Laboratories, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2011-04-054005915307, 005915319
65a5125d27-5258-41ec-b4aa-ca999d97a432 (view SPL)PROMETHAZINE HYDROCHLORIDEprescriptionHuman PrescriptionNorthwind Pharmaceuticals, Llcrepack2015-04-012516550114
66a8fe4bc5-961b-4441-b8e2-ef93e4e137b6 (view SPL)Promethazine Hydrochloride Tablets USPprescriptionHuman PrescriptionAmerican Health Packagingrepack2015-10-214680840154, 680840155
67adb0c2bc-adc3-4f53-a3df-65c48c02d2e4 (view SPL)PROMETHAZINE HYDROCHLORIDE TABLETS, USPprescriptionHuman PrescriptionMedvantx, Inc.REPACK2010-03-101661160605
68b1a95331-12d0-42e8-bb46-ed12d3c212d5 (view SPL)prescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.REPACK2015-01-153687889679
69b29ee375-0846-430c-8dc4-0315d1ac40aa (view SPL)Promethazine Hydrochloride Tablets USPprescriptionHuman PrescriptionCardinal HealthREPACK2015-03-314551544775
70b8231a0f-28d8-40bd-add9-1d7e153ed11e (view SPL)prescriptionHuman PrescriptionClinical Solutions Wholesalerelabel, repack2013-08-112581180107
71ba08126e-9354-406d-bf48-a1ad40900797 (view SPL)Promethazine Hydrochloride Tablets USP Rx onlyprescriptionHuman PrescriptionState Of Florida Doh Central Pharmacyrepack2010-06-011538080546
72ba4ec2d8-1da4-473b-9ef8-57051cb2c0f7 (view SPL)prescriptionHuman PrescriptionNorthwind Pharmaceuticals, Llcrepack2014-06-191516550085
73c0c0d4f0-8396-485b-a585-71df01491f6f (view SPL)Promethazine Hydrochloride Tablets USPprescriptionHuman PrescriptionZydus Pharmaceuticals (Usa) Inc.Analysis, Manufacture2014-11-173683820040
74c222fb52-f1dd-4aa8-80be-b6bd91a04f89 (view SPL)PROMETHAZINE HYDROCHLORIDE TABLETS, USPprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2010-05-272430630049
75cae114cf-6202-4960-8d48-b372b0a7dda7 (view SPL)Promethazine HydrochloridprescriptionHuman PrescriptionUnit Dose ServicesREPACK2012-07-173504364379
76cb5950f9-dc5a-4a30-9f3e-08b006f27dd5 (view SPL)prescriptionHuman PrescriptionCaraco Pharmaceutical Laboratories, Ltd.ANALYSIS, MANUFACTURE, PACK2015-02-268576640107, 576640108, 576640109
77cc3d5cec-5c7a-46cf-ac29-31ec25bdcddb (view SPL)Promethazine Hydrochloride Tablets USP Revised: June 2009 Rx only 190824prescriptionHuman PrescriptionRemedyrepack Inc.2013-10-291521250639
78cff5fbde-a441-4721-8eff-0ed2ed894099 (view SPL)PROMETHAZINE HYDROCHLORIDE TABLETS, USPprescriptionHuman PrescriptionRemedyrepack Inc.2013-09-191521250703
79d3b5ca09-9a02-45bf-a18c-1250ba9be309 (view SPL)PROMETHAZINE HYDROCHLORIDE TABLETS, USPprescriptionHuman PrescriptionQualitest PharmaceuticalsMANUFACTURE2010-03-103006035437, 006035438, 006035439
80d989599c-7691-4157-ada4-c15d29d9112f (view SPL)Promethazine Hydrochloride Tablets USPprescriptionHuman PrescriptionBlenheim Pharmacal, Inc.repack2015-08-284105440512
81da246971-20b8-b46e-8366-9700d3604cf1 (view SPL)Promethazine Hydrochloride Tablets USPprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2014-07-181001636291591
82dbbc9ab7-9459-4ba8-99c2-307cc4257b60 (view SPL)PROMETHAZINE HYDROCHLORIDETablets, USPprescriptionHuman PrescriptionRemedyrepack Inc.2014-10-142617860067
83e027f9dc-da15-4929-8d04-fa931f5a6ef1 (view SPL)Promethazine Hydrochloride Tablets, USPprescriptionHuman PrescriptionRemedyrepack Inc.2013-05-131521250308
84e06c9855-78c7-42f8-b8aa-d3f315675eb4 (view SPL)PROMETHAZINE HYDROCHLORIDE TABLETS, USPprescriptionHuman PrescriptionRemedyrepack Inc.2014-02-261521250566
85e23c09c2-47f5-47c1-825f-cbd8e3440058 (view SPL)PROMETHAZINE 25 MG TABLETSprescriptionHuman PrescriptionStat Rx Usa Llcrelabel, repack2012-04-261425490543
86e849c26d-73a7-46ee-af42-e668e8d9b7bc (view SPL)PROMETHAZINE HYDROCHLORIDE TABLETS, USPprescriptionHuman PrescriptionGolden State Medical Supply, Inc.RELABEL, REPACK2014-09-092604290149, 604290150, 604290151
87f83a009b-d6fe-4277-a522-daa8a6a27156 (view SPL)Promethazine Hydrochloride Tablets USP Revised: June 2009 Rx only 190824prescriptionHuman PrescriptionStat Rx Usa Llcrelabel, repack2012-08-061165900191
88fcfed7b3-32f8-4fbc-ac41-79d7f45df5fc (view SPL)PROMETHAZINE HYDROCHLORIDEprescriptionHuman PrescriptionDirect Rxrelabel, repack2014-04-241619190047
89fe6294e3-2316-4efa-8be3-6e7e81158996 (view SPL)Promethazine Hydrochloride Tablets USPprescriptionHuman PrescriptionTya PharmaceuticalsRELABEL, REPACK2011-05-062647250041
90ff1dddab-72a0-4125-859e-554bece2d2b3 (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2010-06-031548681323, 548682844, 548685121
91ff54560e-c905-4df4-b101-1f19a87af562 (view SPL)Promethazine Hydrochloride 25 mgprescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcmanufacture, repack2010-11-24463499990090

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII