Tramadol Oral Tablet

Brand(s)
Ultram
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Janssen Pharmaceuticals, Inc. (2014-07-28)
Oldest Current Product
1995-03-03
License(s)
NDA, ANDA
RxNORM
ORAL TABLET\TRAMADOL
FDAOB
ORAL\TABLET\TRAMADOL HYDROCHLORIDE
SPL Active
ORAL\TABLET, COATED\TRAMADOL HYDROCHLORIDE
ORAL\TABLET, FILM COATED\TRAMADOL HYDROCHLORIDE
ORAL\TABLET\TRAMADOL HYDROCHLORIDE
SPL Moiety
ORAL\TABLET, COATED\TRAMADOL
ORAL\TABLET, FILM COATED\TRAMADOL
ORAL\TABLET\TRAMADOL

product(s) by strength(s)

tramadol hydrochloride 50 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1504580659UltramNDAJanssen Pharmaceuticals, Inc.1995-03-03TRAMADOL HYDROCHLORIDEORALTABLET, COATEDNDA02028145f59e6f-1794-40a4-8f8b-3a9415924468

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000930058ANDATeva Pharmaceuticals Usa Inc2002-06-20TRAMADOL HYDROCHLORIDEORALTABLET, FILM COATEDANDA0759776d3b4049-2bfd-4874-b984-8fb231bff27c
2003784151ANDAMylan Pharmaceuticals Inc.2002-06-21TRAMADOL HYDROCHLORIDEORALTABLET, FILM COATEDANDA0759863da3815b-fa99-4b20-8564-96d32d84df28
3009046365ANDAMajor2014-02-26TRAMADOL HYDROCHLORIDEORALTABLET, FILM COATEDANDA090404d2aca95d-f27c-4ff8-ac38-29c9f305fa1d
4167140111ANDANorthstar Rx Llc2011-02-16TRAMADOL HYDROCHLORIDEORALTABLETANDA078935485af94f-5ecd-4f25-9774-61ce4cff0921
5167290167ANDAAccord Healthcare Inc.2013-10-01TRAMADOL HYDROCHLORIDEORALTABLETANDA202390052d06ef-4186-4ac1-9099-af05fa37c2f8
6333420201ANDAMacleods Pharmaceuticals Limited2015-10-07TRAMADOL HYDROCHLORIDEORALTABLET, FILM COATEDANDA20570255677592-b577-4299-b7e3-7205a5d5aabb
7576640377ANDACaraco Pharmaceutical Laboratories, Ltd.2002-06-22TRAMADOL HYDROCHLORIDEORALTABLETANDA075964cabccc8a-6f9f-414c-93f0-6dec331ed74b
8605050171ANDAApotex Corp2002-07-10TRAMADOL HYDROCHLORIDEORALTABLET, COATEDANDA0759811c120d54-5eff-d265-56e7-a5cf4aee48f1
9651620627ANDAAmneal Pharmaceuticals2010-11-15TRAMADOL HYDROCHLORIDEORALTABLET, COATEDANDA07600358b802cb-2443-4f5b-9718-7d54c6d50cb4
10658410754ANDACadila Healthcare Limited2011-01-31TRAMADOL HYDROCHLORIDEORALTABLET, FILM COATEDANDA0904046f3a2ab8-f437-456f-ae35-67a965396052
11658620667ANDAAurobindo Pharma Limited2014-03-31TRAMADOL HYDROCHLORIDEORALTABLET, FILM COATEDANDA20349493867bc1-75ac-4194-90b3-d2242c95b3ea
12683820319ANDAZydus Pharmaceuticals (Usa) Inc.2011-01-31TRAMADOL HYDROCHLORIDEORALTABLET, FILM COATEDANDA090404ee7179b7-6a08-4eeb-a787-5d697b02c4a2
13695120627ANDAAlivio Medical Products, Llc2015-10-01TRAMADOL HYDROCHLORIDEORALTABLETANDA076003baaaa16c-48a8-4d92-83ca-319c091dd931
14695430136ANDAVirtus Pharmaceuticals2015-05-22TRAMADOL HYDROCHLORIDEORALTABLETANDA09149813acd63b-3e08-476f-9fb3-4695c793112f
15764390136ANDAVirtus Pharmaceuticals2014-02-20TRAMADOL HYDROCHLORIDEORALTABLET, FILM COATEDANDA09149856dafd4d-6fa6-4579-8634-e02ec978c37b

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1006157810ANDANcs Healthcare Of Ky, Inc Dba Vangard Labs2002-06-21TRAMADOL HYDROCHLORIDEORALTABLET, FILM COATED003784151ANDA075986f6d34d61-9175-4106-a497-0598b25212fa
2009046119ANDAMajor2010-03-01TRAMADOL HYDROCHLORIDEORALTABLET651620627ANDA076003cc765ec6-b427-47e8-bff7-f46de53304cb
3105440009ANDABlenheim Pharmacal, Inc.2010-08-13TRAMADOL HYDROCHLORIDEORALTABLET651620627ANDA0760033981b2f1-3045-4a37-96e1-059e913e85aa
4105440531ANDABlenheim Pharmacal, Inc.2010-04-07TRAMADOL HYDROCHLORIDEORALTABLET651620627ANDA07600358c2975a-47bd-4d3c-9cfe-9ea59f3f31ca
5126340786ANDAApotheca, Inc2005-04-26TRAMADOL HYDROCHLORIDEORALTABLET651620627ANDA075964dddcfc5c-e97c-494d-ab17-046455abbb4a
6165900229ANDAStat Rx Usa Llc2002-06-22TRAMADOL HYDROCHLORIDEORALTABLET576640377ANDA075964d5576a76-b16c-4db2-a762-c03194b1e44c
7216950132ANDARebel Distributors Corp2009-11-23TRAMADOL HYDROCHLORIDEORALTABLET651620627ANDA076003ba1be142-668f-41de-a545-852e1e8ff852
8242360609ANDARemedyrepack Inc.2011-12-05, 2013-07-29, 2013-07-31, 2013-11-12TRAMADOL HYDROCHLORIDEORALTABLET651620627ANDA0760031fcc7e17-e69e-4e22-b369-3fff032773fe, 80518cac-485d-48af-90c8-81c3eac8757e, a7d7bd03-145a-4398-bfb4-b8d404aa6fa2, d5ab4f08-1d12-4c64-b3bf-e72c705aeca8
9332610105ANDAAidarex Pharmaceuticals Llc2010-11-15TRAMADOL HYDROCHLORIDEORALTABLET, COATED651620627ANDA076003ac536879-c38b-4012-ae72-655ff9866691
10332610483ANDAAidarex Pharmaceuticals Llc2002-06-22TRAMADOL HYDROCHLORIDEORALTABLET576640377ANDA07596438da58e9-79a6-447d-a07c-0f0084fb03ff
11333580342ANDARxchange Co.2014-11-14TRAMADOL HYDROCHLORIDEORALTABLET, COATED651620627ANDA07600319f1f780-9b4e-43a6-a758-9d7a3e5e4a60
12353560659ANDALake Erie Medical Dba Quality Care Products Llc2009-11-23TRAMADOL HYDROCHLORIDEORALTABLET651620627ANDA0760037482c886-417f-46c5-9ed6-be7418e0c33b
13425490527ANDAStat Rx Usa Llc2009-11-23TRAMADOL HYDROCHLORIDEORALTABLET651620627ANDA0760031a545dca-978d-4091-9917-9074cf6957b2
14430630055ANDAPd-Rx Pharmaceuticals, Inc.2010-11-15TRAMADOL HYDROCHLORIDEORALTABLET, COATED651620627ANDA076003be4a5da1-38d2-4bb4-9d0b-51f5c3c6cb2b
15433530072ANDAAphena Pharma Solutions - Tennessee, Llc2010-11-15TRAMADOL HYDROCHLORIDEORALTABLET, COATED651620627ANDA076003648d4e25-d72d-4434-b5fe-119b6c586afe
16458650357ANDAMedsource Pharmaceuticals2014-02-14TRAMADOL HYDROCHLORIDEORALTABLET, FILM COATED764390136ANDA0914981b439a3a-3199-43fd-e054-00144ff88e88
17493490077ANDARemedyrepack Inc.2010-11-17TRAMADOL HYDROCHLORIDEORALTABLET651620627ANDA076003ba29b053-3eb6-4dc8-b8a9-fffce9cca121
18493490541ANDARemedyrepack Inc.2011-09-28, 2013-07-25TRAMADOL HYDROCHLORIDEORALTABLET651620627ANDA0760037d5fbee5-a8e7-4f5d-954a-ed6623ba2f19, ae07935c-086d-40e7-9ca5-37e9bdfdca17
19499990022UltramNDALake Erie Medical Dba Quality Care Products Llc2012-03-20TRAMADOL HYDROCHLORIDEORALTABLET, COATED504580659NDA020281afc36069-62f2-458c-aefd-dda8d8764a80
20499990129ANDALake Erie Medical Dba Quality Care Products Llc2011-02-07TRAMADOL HYDROCHLORIDEORALTABLET576640377ANDA0759645fd73b94-8e76-4274-8259-7c353bc1a32d
21500900531UltramNDAA-S Medication Solutions Llc1995-03-03TRAMADOL HYDROCHLORIDEORALTABLET, COATED504580659NDA0202811b1b16fd-766e-464e-a0dd-b4cc10bfd2aa
22500900806ANDAA-S Medication Solutions Llc2002-06-22TRAMADOL HYDROCHLORIDEORALTABLET576640377ANDA07596408205443-f1db-4019-a95c-8b5025df0ae0
23500900807ANDAA-S Medication Solutions Llc2002-06-22TRAMADOL HYDROCHLORIDEORALTABLET576640377ANDA075964c42fcf3f-9625-469b-b437-486c41d0531b
24504368787ANDAUnit Dose Services2010-11-15TRAMADOL HYDROCHLORIDEORALTABLET, COATED651620627ANDA07600337ce0483-afde-4859-b160-e81c0ecd5506
25510790991ANDAMylan Institutional Inc.2002-08-01TRAMADOL HYDROCHLORIDEORALTABLET, FILM COATED003784151ANDA075986f05e00b3-25d1-4d96-a5d0-f6260b2507ac
26511380077ANDAMed-Health Pharma, Llc2011-01-01TRAMADOL HYDROCHLORIDEORALTABLET651620627ANDA076003efb84d69-fbc8-43a5-9c27-73fc8b665dd4
27516550185UltramANDANorthwind Pharmaceuticals, Llc2014-02-13TRAMADOL HYDROCHLORIDEORALTABLET, COATED651620627ANDA0760033f12e8b3-ccf5-4b7d-a370-9596e5002b10
28521250277ANDARemedyrepack Inc.2013-06-04TRAMADOL HYDROCHLORIDEORALTABLET, FILM COATED683820319ANDA09040496001b7a-318b-467b-a62a-f4db36943f7d
29521250298ANDARemedyrepack Inc.2013-05-07TRAMADOL HYDROCHLORIDEORALTABLET, FILM COATED000930058ANDA07597702c58fe6-5a7a-49ce-9d82-2b7021d7716e
30521250377ANDARemedyrepack Inc.2013-05-13TRAMADOL HYDROCHLORIDEORALTABLET, COATED651620627ANDA076003fabfa59b-d41c-4292-a569-e0461bbbfeb7
31545694089UltramNDAA-S Medication Solutions Llc1995-03-03TRAMADOL HYDROCHLORIDEORALTABLET, COATED504580659NDA020281288ddb7b-29e4-46c7-9d84-38a188231710
32545695436ANDAA-S Medication Solutions Llc2002-06-22TRAMADOL HYDROCHLORIDEORALTABLET576640377ANDA075964b8b5fb31-efe5-42c1-a027-aa96b3e8bbe5
33545695967ANDAA-S Medication Solutions Llc2002-06-22TRAMADOL HYDROCHLORIDEORALTABLET576640377ANDA075964abdfd734-d4a4-459a-b1b7-9de8aa84277b
34548684638ANDAPhysicians Total Care, Inc.2002-06-21TRAMADOL HYDROCHLORIDEORALTABLET, COATED651620627ANDA07600354662ff4-10d8-425f-a2ae-978715093da1
35551542537ANDACardinal Health2010-11-15TRAMADOL HYDROCHLORIDEORALTABLET, COATED651620627ANDA076003678cc410-9552-443b-b85b-a156dda4c10a
36551542541ANDACardinal Health2010-11-15TRAMADOL HYDROCHLORIDEORALTABLET, COATED651620627ANDA0760030d5cd67a-a529-4391-b8c2-33934b860dbe
37551543333ANDACardinal Health2010-03-01TRAMADOL HYDROCHLORIDEORALTABLET009046119ANDA0760036dd27372-b746-4598-893d-29a553b7c28b
38551544566ANDACardinal Health2002-06-22TRAMADOL HYDROCHLORIDEORALTABLET576640377ANDA075964d68d7544-2896-4d55-be08-bc29cf7321d9
39551544791ANDACardinal Health2010-03-23TRAMADOL HYDROCHLORIDEORALTABLET625840559ANDA076003ad58cca8-4bc3-4b9b-b472-16e8f5e62cd8
40551545656ANDACardinal Health2011-02-04TRAMADOL HYDROCHLORIDEORALTABLET, FILM COATED510790991ANDA075986ca026c60-a160-4e42-bff4-be774526891b
41551546239ANDACardinal Health2002-06-21TRAMADOL HYDROCHLORIDEORALTABLET, FILM COATED003784151ANDA075986bc3ecbf6-0abe-44bf-97a4-630fb5b92320
42552890650UltramNDAPd-Rx Pharmaceuticals, Inc.1995-03-03TRAMADOL HYDROCHLORIDEORALTABLET, COATED504580659NDA02028134ef3f2e-883d-431e-a6cd-b351a0d2c9bb
43552890719ANDAPd-Rx Pharmaceuticals, Inc.2010-11-15TRAMADOL HYDROCHLORIDEORALTABLET, COATED651620627ANDA076003be6a60be-a6be-4d62-96a3-30441fcdcd0b
44607600377ANDASt Marys Medical Park Pharmacy2014-10-06TRAMADOL HYDROCHLORIDEORALTABLET576640377ANDA075964a4ca14c8-758c-41f9-a1b9-9a3d03d05166
45617860199ANDARemedyrepack Inc.2015-02-26, 2015-07-22TRAMADOL HYDROCHLORIDEORALTABLET, FILM COATED764390136ANDA0914983499eff7-b982-431f-b4be-f43e72c26d89, b98bbcb6-1d01-4092-a445-f30e3a00a407
46619190073ANDADirect Rx2014-01-01TRAMADOL HYDROCHLORIDEORALTABLET, COATED651620627ANDA0760034a17d714-9151-4e20-bfab-3deddbf8e04f
47619190229ANDADirect Rx2014-01-01TRAMADOL HYDROCHLORIDEORALTABLET576640377ANDA075964f4ae0017-5050-4b92-9944-340385152b95
48631870063ANDAProficient Rx Lp2010-11-15TRAMADOL HYDROCHLORIDEORALTABLET, COATED651620627ANDA07600350f4b752-20af-4ebf-9408-e78f30d2a3cc
49636294394ANDABryant Ranch Prepack2002-06-22TRAMADOL HYDROCHLORIDEORALTABLET576640377ANDA075964d15a592c-d02b-5bf9-11bb-005141ce5472
50636294899ANDABryant Ranch Prepack2010-11-15TRAMADOL HYDROCHLORIDEORALTABLET, COATED651620627ANDA076003ce0173f9-1273-4ef9-9391-554b4884bcdd
51637390671ANDAMckesson Packaging Services A Business Unit Of Mckesson Corporation2013-12-02TRAMADOL HYDROCHLORIDEORALTABLET, COATED651620627ANDA07600335de6124-09a7-4afd-9713-a1c91df1bbe8
52638740532ANDAAltura Pharmaceuticals, Inc.2010-01-01TRAMADOL HYDROCHLORIDEORALTABLET651620627ANDA0760034acbc6df-7616-413c-bcca-2be75a176dcf
53642050627ANDAReadymeds2010-11-15TRAMADOL HYDROCHLORIDEORALTABLET, COATED651620627ANDA07600368b8197c-eb86-4bb4-84bd-45cc9c048c49
54663360915ANDADispensing Solutions, Inc.2002-06-22TRAMADOL HYDROCHLORIDEORALTABLET576640377ANDA07596442624fb5-5518-4fae-bf40-5ba69e16240b
55670460730ANDAContract Pharmacy Services-Pa2010-02-26TRAMADOL HYDROCHLORIDEORALTABLET651620627ANDA076003903993bc-2f60-4a60-a787-03945d1abd46
56680840808ANDAAmerican Health Packaging2014-08-21TRAMADOL HYDROCHLORIDEORALTABLET, COATED651620627ANDA0760039893b6c0-fe47-4e56-8857-d3a5a888b9fd
57683870900ANDAKeltman Pharmaceuticals Inc.2009-06-30TRAMADOL HYDROCHLORIDEORALTABLET651620627ANDA076003340a7760-50b1-4825-9766-eaaad0dd7712
58687889199ANDAPreferred Pharmaceuticals, Inc.2009-11-23TRAMADOL HYDROCHLORIDEORALTABLET651620627ANDA07600394a85fdc-6b17-4af8-a0c9-a7cda7c5a686
59687889304ANDAPreferred Pharmaceuticals, Inc.2015-04-15TRAMADOL HYDROCHLORIDEORALTABLET, FILM COATED764390136ANDA091498e35d447b-341e-4a3f-a18b-fa51f43098ca
60759210627ANDALife Line Home Care Services, Inc.2011-01-01TRAMADOL HYDROCHLORIDEORALTABLET651620627ANDA076003257512ba-1ede-4332-8d89-2a6dd6b1a3c5
61762370253ANDAMckesson Contract Packaging2011-10-19TRAMADOL HYDROCHLORIDEORALTABLET, FILM COATED003784151ANDA075986d832d94d-454c-4f83-addc-ed349a269231

application(s)

#idtitledeprecatedapplicantapprovedpatentapproved drug
1ANDA075960TRAMADOL HYDROCHLORIDETrueACTAVIS ELIZABETH LLC2002-06-19ANDA075960_001
2ANDA075962TRAMADOL HYDROCHLORIDETrueWATSON LABORATORIES2002-06-24ANDA075962_001
3ANDA075963TRAMADOL HYDROCHLORIDETrueIVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA2002-07-03ANDA075963_001
4ANDA075964TRAMADOL HYDROCHLORIDESUN PHARMACEUTICAL INDUSTRIES INC2002-06-19ANDA075964_001
5ANDA075968TRAMADOL HYDROCHLORIDETrueSANDOZ2002-06-25ANDA075968_001
6ANDA075974TRAMADOL HYDROCHLORIDETrueASTA MEDICA INC2002-07-12ANDA075974_001
7ANDA075977TRAMADOL HYDROCHLORIDETEVA PHARMACEUTICALS USA INC2002-06-19ANDA075977_001
8ANDA075980TRAMADOL HYDROCHLORIDEMYLAN PHARMACEUTICALS INC2002-11-21ANDA075980_001
9ANDA075981TRAMADOL HYDROCHLORIDEAPOTEX INC2002-07-10ANDA075981_001
10ANDA075982TRAMADOL HYDROCHLORIDEPLIVA INC2002-07-01ANDA075982_001
11ANDA075983TRAMADOL HYDROCHLORIDEMALLINCKRODT INC2002-06-25ANDA075983_001
12ANDA075986TRAMADOL HYDROCHLORIDEMYLAN PHARMACEUTICALS INC2002-06-21ANDA075986_001
13ANDA076003TRAMADOL HYDROCHLORIDEAMNEAL PHARMACEUTICALS LLC2002-06-20ANDA076003_001
14ANDA076100TRAMADOL HYDROCHLORIDEMUTUAL PHARMACEUTICAL CO INC2002-06-20ANDA076100_001
15ANDA078935TRAMADOL HYDROCHLORIDENORTHSTAR HEALTHCARE HOLDINGS LTD2010-05-26ANDA078935_001
16ANDA090404TRAMADOL HYDROCHLORIDEZYDUS PHARMACEUTICALS USA INC2011-01-31ANDA090404_001
17ANDA091498TRAMADOL HYDROCHLORIDECSPC OUYI PHARMACEUTICAL CO LTD2013-03-29ANDA091498_001
18ANDA201973TRAMADOL HYDROCHLORIDEIPCA LABORATORIES LTD2012-11-16ANDA201973_001
19ANDA202075TRAMADOL HYDROCHLORIDEALLIED PHARMA INC2011-11-28ANDA202075_001
20ANDA202390TRAMADOL HYDROCHLORIDEACCORD HEALTHCARE INC USA2013-05-16ANDA202390_001
21ANDA203494TRAMADOL HYDROCHLORIDEAUROBINDO PHARMA LTD2014-03-31ANDA203494_001
22ANDA205702TRAMADOL HYDROCHLORIDEMACLEODS PHARMACEUTICALS LTD2015-09-25ANDA205702_001
23NDA020281ULTRAMJANSSEN PHARMACEUTICALS INC1995-03-03p6339105, A TITRATION DOSING REGIMEN FOR THE TREATMENT OF PAIN USING AN INITIAL DOSE OF ABOUT 25MGNDA020281_001, NDA020281_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA075960_001discontinuedTRAMADOL HYDROCHLORIDE (50MG)ORALTABLETFalse2002-06-19TRAMADOL HYDROCHLORIDE
2ANDA075962_001discontinuedTRAMADOL HYDROCHLORIDE (50MG)ORALTABLETFalse2002-06-24TRAMADOL HYDROCHLORIDE
3ANDA075963_001discontinuedTRAMADOL HYDROCHLORIDE (50MG)ORALTABLETFalse2002-07-03TRAMADOL HYDROCHLORIDE
4ANDA075964_001RXTRAMADOL HYDROCHLORIDE (50MG)ORALTABLETFalseAB2002-06-19TRAMADOL HYDROCHLORIDE
5ANDA075968_001discontinuedTRAMADOL HYDROCHLORIDE (50MG)ORALTABLETFalse2002-06-25TRAMADOL HYDROCHLORIDE
6ANDA075974_001discontinuedTRAMADOL HYDROCHLORIDE (50MG)ORALTABLETFalse2002-07-12TRAMADOL HYDROCHLORIDE
7ANDA075977_001RXTRAMADOL HYDROCHLORIDE (50MG)ORALTABLETFalseAB2002-06-19TRAMADOL HYDROCHLORIDE
8ANDA075980_001RXTRAMADOL HYDROCHLORIDE (50MG)ORALTABLETFalseAB2002-11-21TRAMADOL HYDROCHLORIDE
9ANDA075981_001RXTRAMADOL HYDROCHLORIDE (50MG)ORALTABLETFalseAB2002-07-10TRAMADOL HYDROCHLORIDE
10ANDA075982_001RXTRAMADOL HYDROCHLORIDE (50MG)ORALTABLETFalseAB2002-07-01TRAMADOL HYDROCHLORIDE
11ANDA075983_001RXTRAMADOL HYDROCHLORIDE (50MG)ORALTABLETFalseAB2002-06-25TRAMADOL HYDROCHLORIDE
12ANDA075986_001RXTRAMADOL HYDROCHLORIDE (50MG)ORALTABLETFalseAB2002-06-21TRAMADOL HYDROCHLORIDE
13ANDA076003_001RXTRAMADOL HYDROCHLORIDE (50MG)ORALTABLETFalseAB2002-06-20TRAMADOL HYDROCHLORIDE
14ANDA076100_001RXTRAMADOL HYDROCHLORIDE (50MG)ORALTABLETFalseAB2002-06-20TRAMADOL HYDROCHLORIDE
15ANDA078935_001RXTRAMADOL HYDROCHLORIDE (50MG)ORALTABLETFalseAB2010-05-26TRAMADOL HYDROCHLORIDE
16ANDA090404_001RXTRAMADOL HYDROCHLORIDE (50MG)ORALTABLETFalseAB2011-01-31TRAMADOL HYDROCHLORIDE
17ANDA091498_001RXTRAMADOL HYDROCHLORIDE (50MG)ORALTABLETFalseAB2013-03-29TRAMADOL HYDROCHLORIDE
18ANDA201973_001RXTRAMADOL HYDROCHLORIDE (50MG)ORALTABLETFalseAB2012-11-16TRAMADOL HYDROCHLORIDE
19ANDA202075_001RXTRAMADOL HYDROCHLORIDE (50MG)ORALTABLETFalseAB2011-11-28TRAMADOL HYDROCHLORIDE
20ANDA202390_001RXTRAMADOL HYDROCHLORIDE (50MG)ORALTABLETFalseAB2013-05-16TRAMADOL HYDROCHLORIDE
21ANDA203494_001RXTRAMADOL HYDROCHLORIDE (50MG)ORALTABLETFalseAB2014-03-31TRAMADOL HYDROCHLORIDE
22ANDA205702_001RXTRAMADOL HYDROCHLORIDE (50MG)ORALTABLETFalseAB2015-09-25TRAMADOL HYDROCHLORIDE
23NDA020281_001discontinuedTRAMADOL HYDROCHLORIDE (100MG)ORALTABLETFalse1995-03-03ULTRAM
24NDA020281_002RXTRAMADOL HYDROCHLORIDE (50MG)ORALTABLETTrueAB1995-03-03ULTRAM

patent(s)

#idexpiration dateapplication(s)
1p6339105 (view patent)2019-10-12NDA020281

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
102c58fe6-5a7a-49ce-9d82-2b7021d7716e (view SPL)TRAMADOL HYDROCHLORIDE TABLETS USP, 50 mg0058prescriptionHuman PrescriptionRemedyrepack Inc.2013-05-071521250298
2052d06ef-4186-4ac1-9099-af05fa37c2f8 (view SPL)Tramadol Hydrochloride Tablets USP CIVprescriptionHuman PrescriptionAccord Healthcare Inc.analysis, manufacture2014-09-304167290167
308205443-f1db-4019-a95c-8b5025df0ae0 (view SPL)Tramadol Hydrochloride Tablets, USP, CIV50 mg - Rx onlyprescriptionHuman PrescriptionA-S Medication Solutions Llcrepack2014-12-151500900806
40d5cd67a-a529-4391-b8c2-33934b860dbe (view SPL)Tramadol Hydrochloride Tablets, USP CIV Rx onlyprescriptionHuman PrescriptionCardinal HealthREPACK2015-06-031551542541
513acd63b-3e08-476f-9fb3-4695c793112f (view SPL)TRAMADOL HYDROCHLORIDE - Tramadol Hydrochloride Tablets, USP CIVprescriptionHuman PrescriptionVirtus Pharmaceuticals2015-05-291695430136
619f1f780-9b4e-43a6-a758-9d7a3e5e4a60 (view SPL)Tramadol Hydrochloride Tablets, USP CIV Rx onlyprescriptionHuman PrescriptionRxchange Co.manufacture2014-12-012333580342
71a545dca-978d-4091-9917-9074cf6957b2 (view SPL)Tramadol Hydrochloride TabletsprescriptionHuman PrescriptionStat Rx Usa LlcRELABEL, REPACK2011-02-146425490527
81b1b16fd-766e-464e-a0dd-b4cc10bfd2aa (view SPL)ULTRAM C IV (tramadol hydrochloride) TabletsprescriptionHuman PrescriptionA-S Medication Solutions Llcrepack2014-12-151500900531
91b439a3a-3199-43fd-e054-00144ff88e88 (view SPL)TRAMADOL HYDROCHLORIDE - Tramadol Hydrochloride Tablets, USP, FULL PRESCRIBING INFORMATIONprescriptionHuman PrescriptionMedsource Pharmaceuticalsrepack2015-07-194458650357
101c120d54-5eff-d265-56e7-a5cf4aee48f1 (view SPL)Tramadol Hydrochloride Tablets, USP CIVprescriptionHuman PrescriptionApotex Corpanalysis, manufacture2012-02-015605050171
111fcc7e17-e69e-4e22-b369-3fff032773fe (view SPL)Tramadol Hydrochloride Tablets, USPprescriptionHuman PrescriptionRemedyrepack Inc.2013-07-313242360609
12257512ba-1ede-4332-8d89-2a6dd6b1a3c5 (view SPL)Tramadol Hydrochloride TabletsprescriptionHuman PrescriptionLife Line Home Care Services, Inc.relabel, repack2012-03-151759210627
13288ddb7b-29e4-46c7-9d84-38a188231710 (view SPL)ULTRAM C IV (tramadol hydrochloride) TabletsprescriptionHuman PrescriptionA-S Medication Solutions Llcrepack2014-10-121545694089
14340a7760-50b1-4825-9766-eaaad0dd7712 (view SPL)Tramadol Hydrochloride TabletsprescriptionHuman PrescriptionKeltman Pharmaceuticals Inc.repack2010-08-091683870900
153499eff7-b982-431f-b4be-f43e72c26d89 (view SPL)TRAMADOL HYDROCHLORIDE - Tramadol Hydrochloride Tablets, USP, FULL PRESCRIBING INFORMATIONprescriptionHuman PrescriptionRemedyrepack Inc.2015-02-261617860199
1634ef3f2e-883d-431e-a6cd-b351a0d2c9bb (view SPL)ULTRAM C IV (tramadol hydrochloride) TabletsprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2014-07-287552890650
1735de6124-09a7-4afd-9713-a1c91df1bbe8 (view SPL)Tramadol Hydrochloride Tablets, USP CIVprescriptionHuman PrescriptionMckesson Packaging Services A Business Unit Of Mckesson CorporationREPACK2014-07-142637390671
1837ce0483-afde-4859-b160-e81c0ecd5506 (view SPL)Tramadol Hydrochloride Tablets, USP CIV Rx onlyprescriptionHuman PrescriptionUnit Dose ServicesREPACK2014-07-159504368787
1938da58e9-79a6-447d-a07c-0f0084fb03ff (view SPL)Tramadol Hydrochloride Tablets, USP50 mg - Rx onlyprescriptionHuman PrescriptionAidarex Pharmaceuticals Llc2012-10-051332610483
203981b2f1-3045-4a37-96e1-059e913e85aa (view SPL)Tramadol Hydrochloride TabletsprescriptionHuman PrescriptionBlenheim Pharmacal, Inc.RELABEL, REPACK2014-01-012105440009
213da3815b-fa99-4b20-8564-96d32d84df28 (view SPL)prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2014-07-155003784151
223f12e8b3-ccf5-4b7d-a370-9596e5002b10 (view SPL)prescriptionHuman PrescriptionNorthwind Pharmaceuticals, Llcrepack2014-02-141516550185
2342624fb5-5518-4fae-bf40-5ba69e16240b (view SPL)Tramadol Hydrochloride Tablets, USP50 mg - Rx onlyprescriptionHuman PrescriptionDispensing Solutions, Inc.relabel2013-11-073663360915
2445f59e6f-1794-40a4-8f8b-3a9415924468 (view SPL)ULTRAM C IV (tramadol hydrochloride) TabletsprescriptionHuman PrescriptionJanssen Pharmaceuticals, Inc.ANALYSIS, API MANUFACTURE, MANUFACTURE2014-07-286504580659
25485af94f-5ecd-4f25-9774-61ce4cff0921 (view SPL)Rx Only CIVprescriptionHuman PrescriptionNorthstar Rx LlcANALYSIS, MANUFACTURE, PACK2015-05-219167140111
264a17d714-9151-4e20-bfab-3deddbf8e04f (view SPL)TRAMADOL HYDROCHLORIDEprescriptionHuman PrescriptionDirect Rxrelabel, repack2015-11-023619190073
274acbc6df-7616-413c-bcca-2be75a176dcf (view SPL)Tramadol Hydrochloride TabletsprescriptionHuman PrescriptionAltura Pharmaceuticals, Inc.relabel, repack2010-04-092638740532
2850f4b752-20af-4ebf-9408-e78f30d2a3cc (view SPL)Tramadol Hydrochloride C-IV Tablets, USPprescriptionHuman PrescriptionProficient Rx LpRELABEL, REPACK2014-04-302631870063
2954662ff4-10d8-425f-a2ae-978715093da1 (view SPL)Tramadol Hydrochloride Tablets, USPprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2013-07-106548684638
3055677592-b577-4299-b7e3-7205a5d5aabb (view SPL)Tramadol Hydrochloride Tablets, USP, CIVRx OnlyprescriptionHuman PrescriptionMacleods Pharmaceuticals LimitedANALYSIS, LABEL, MANUFACTURE, PACK2015-10-071333420201
3156dafd4d-6fa6-4579-8634-e02ec978c37b (view SPL)TRAMADOL HYDROCHLORIDE - Tramadol Hydrochloride Tablets, USP, FULL PRESCRIBING INFORMATIONprescriptionHuman PrescriptionVirtus PharmaceuticalsMANUFACTURE2015-08-032764390136
3258b802cb-2443-4f5b-9718-7d54c6d50cb4 (view SPL)Tramadol Hydrochloride Tablets, USP CIV Rx onlyprescriptionHuman PrescriptionAmneal PharmaceuticalsANALYSIS, LABEL, MANUFACTURE, PACK, REPACK2015-11-2017651620627
3358c2975a-47bd-4d3c-9cfe-9ea59f3f31ca (view SPL)Tramadol Hydrochloride TabletsprescriptionHuman PrescriptionBlenheim Pharmacal, Inc.RELABEL, REPACK2014-01-013105440531
345fd73b94-8e76-4274-8259-7c353bc1a32d (view SPL)TRAMADOL HYDROCHLORIDE TABLETS50 mg - Rx onlyprescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products LlcManufacture, repack2011-12-073342499990129
35648d4e25-d72d-4434-b5fe-119b6c586afe (view SPL)Tramadol Hydrochloride Tablets, USP CIV Rx onlyprescriptionHuman PrescriptionAphena Pharma Solutions - Tennessee, LlcRepack2014-07-184433530072
36678cc410-9552-443b-b85b-a156dda4c10a (view SPL)Tramadol Hydrochloride Tablets, USPprescriptionHuman PrescriptionCardinal HealthREPACK2013-03-051551542537
3768b8197c-eb86-4bb4-84bd-45cc9c048c49 (view SPL)Tramadol Hydrochloride Tablets, USPprescriptionHuman PrescriptionReadymedsrepack2014-05-1511642050627
386d3b4049-2bfd-4874-b984-8fb231bff27c (view SPL)TRAMADOL HYDROCHLORIDE TABLETS USP, 50 mg 0058prescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2014-08-188000930058
396dd27372-b746-4598-893d-29a553b7c28b (view SPL)Tramadol Hydrochloride TabletsprescriptionHuman PrescriptionCardinal HealthREPACK2013-03-222551543333
406f3a2ab8-f437-456f-ae35-67a965396052 (view SPL)Tramadol Hydrochloride Tablets, USPprescriptionHuman PrescriptionCadila Healthcare LimitedAnalysis, Manufacture2011-04-191658410754
417482c886-417f-46c5-9ed6-be7418e0c33b (view SPL)Tramadol Hydrochloride TabletsprescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products LlcREPACK2014-10-093958353560659
427d5fbee5-a8e7-4f5d-954a-ed6623ba2f19 (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2011-09-281493490541
4380518cac-485d-48af-90c8-81c3eac8757e (view SPL)Tramadol Hydrochloride Tablets, USPprescriptionHuman PrescriptionRemedyrepack Inc.2013-11-122242360609
44903993bc-2f60-4a60-a787-03945d1abd46 (view SPL)Tramadol Hydrochloride TabletsprescriptionHuman PrescriptionContract Pharmacy Services-Pa2010-08-172670460730
4593867bc1-75ac-4194-90b3-d2242c95b3ea (view SPL)Tramadol Hydrochloride Tablets, USP CIV Rx only Full Prescribing InformationprescriptionHuman PrescriptionAurobindo Pharma LimitedANALYSIS, API MANUFACTURE, MANUFACTURE2014-09-123658620667
4694a85fdc-6b17-4af8-a0c9-a7cda7c5a686 (view SPL)Tramadol Hydrochloride Tablets, USP CIVRx onlyprescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.REPACK2015-01-143687889199
4796001b7a-318b-467b-a62a-f4db36943f7d (view SPL)Tramadol Hydrochloride Tablets, USPprescriptionHuman PrescriptionRemedyrepack Inc.2013-06-041521250277
489893b6c0-fe47-4e56-8857-d3a5a888b9fd (view SPL)Tramadol Hydrochloride Tablets, USPCIVprescriptionHuman PrescriptionAmerican Health PackagingREPACK2014-08-251680840808
49a4ca14c8-758c-41f9-a1b9-9a3d03d05166 (view SPL)Tramadol Hydrochloride Tablets, USP, CIV50 mg - Rx onlyprescriptionHuman PrescriptionSt Marys Medical Park PharmacyRELABEL, REPACK, manufacture2014-10-221607600377
50a7d7bd03-145a-4398-bfb4-b8d404aa6fa2 (view SPL)Tramadol Hydrochloride Tablets, USPprescriptionHuman PrescriptionRemedyrepack Inc.2013-07-293242360609
51abdfd734-d4a4-459a-b1b7-9de8aa84277b (view SPL)Tramadol Hydrochloride Tablets, USP, CIV50 mg - Rx onlyprescriptionHuman PrescriptionA-S Medication Solutions Llcrepack2014-10-121545695967
52ac536879-c38b-4012-ae72-655ff9866691 (view SPL)Tramadol Hydrochloride Tablets, USPprescriptionHuman PrescriptionAidarex Pharmaceuticals Llc2012-10-052332610105
53ad58cca8-4bc3-4b9b-b472-16e8f5e62cd8 (view SPL)Tramadol Hydrochloride TabletsprescriptionHuman PrescriptionCardinal HealthREPACK2014-06-032551544791
54ae07935c-086d-40e7-9ca5-37e9bdfdca17 (view SPL)Tramadol Hydrochloride Tablets, USPprescriptionHuman PrescriptionRemedyrepack Inc.2013-07-254493490541
55afc36069-62f2-458c-aefd-dda8d8764a80 (view SPL)ULTRAM (tramadol hydrochloride) TabletsprescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrepack2012-11-283685499990022
56b8b5fb31-efe5-42c1-a027-aa96b3e8bbe5 (view SPL)Tramadol Hydrochloride Tablets, USP, CIV50 mg - Rx onlyprescriptionHuman PrescriptionA-S Medication Solutions Llcrepack2014-10-121545695436
57b98bbcb6-1d01-4092-a445-f30e3a00a407 (view SPL)TRAMADOL HYDROCHLORIDE - Tramadol Hydrochloride Tablets, USP, FULL PRESCRIBING INFORMATIONprescriptionHuman PrescriptionRemedyrepack Inc.2015-07-221617860199
58ba1be142-668f-41de-a545-852e1e8ff852 (view SPL)Tramadol Hydrochloride TabletsprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2010-05-031216950132
59ba29b053-3eb6-4dc8-b8a9-fffce9cca121 (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2010-11-1790493490077
60baaaa16c-48a8-4d92-83ca-319c091dd931 (view SPL)Drug FactsprescriptionHuman PrescriptionAlivio Medical Products, Llc2015-10-162695120627
61bc3ecbf6-0abe-44bf-97a4-630fb5b92320 (view SPL)TRAMADOL HYDROCHLORIDE TABLETS50 mgprescriptionHuman PrescriptionCardinal HealthREPACK2011-05-171551546239
62be4a5da1-38d2-4bb4-9d0b-51f5c3c6cb2b (view SPL)Tramadol Hydrochloride Tablets, USP CIV Rx onlyprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2014-07-1513430630055
63be6a60be-a6be-4d62-96a3-30441fcdcd0b (view SPL)Tramadol Hydrochloride Tablets, USP CIV Rx onlyprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2014-07-1515552890719
64c42fcf3f-9625-469b-b437-486c41d0531b (view SPL)Tramadol Hydrochloride Tablets, USP, CIV50 mg - Rx onlyprescriptionHuman PrescriptionA-S Medication Solutions Llcrepack2014-12-151500900807
65ca026c60-a160-4e42-bff4-be774526891b (view SPL)prescriptionHuman PrescriptionCardinal HealthREPACK2014-10-086551545656
66cabccc8a-6f9f-414c-93f0-6dec331ed74b (view SPL)Tramadol Hydrochloride Tablets, USP, CIV50 mg - Rx onlyprescriptionHuman PrescriptionCaraco Pharmaceutical Laboratories, Ltd.MANUFACTURE, RELABEL, REPACK2014-08-2812576640377
67cc765ec6-b427-47e8-bff7-f46de53304cb (view SPL)Tramadol Hydrochloride TabletsprescriptionHuman PrescriptionMajor2012-07-197009046119
68ce0173f9-1273-4ef9-9391-554b4884bcdd (view SPL)Tramadol Hydrochloride Tablets, USPprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2014-05-051006636294899
69d15a592c-d02b-5bf9-11bb-005141ce5472 (view SPL)Tramadol Hydrochloride Tablets, USPprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2012-10-122636294394
70d2aca95d-f27c-4ff8-ac38-29c9f305fa1d (view SPL)Tramadol Hydrochloride Tablets, USPprescriptionHuman PrescriptionMajor2014-10-022009046365
71d5576a76-b16c-4db2-a762-c03194b1e44c (view SPL)Tramadol Hydrochloride Tablets, USP50 mg - Rx onlyprescriptionHuman PrescriptionStat Rx Usa Llcrelabel, repack2012-08-221165900229
72d5ab4f08-1d12-4c64-b3bf-e72c705aeca8 (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2011-12-052242360609
73d68d7544-2896-4d55-be08-bc29cf7321d9 (view SPL)Tramadol Hydrochloride Tablets, USP, CIV 50 mg - Rx onlyprescriptionHuman PrescriptionCardinal HealthREPACK2015-05-069551544566
74d832d94d-454c-4f83-addc-ed349a269231 (view SPL)prescriptionHuman PrescriptionMckesson Contract PackagingREPACK2014-08-113762370253
75dddcfc5c-e97c-494d-ab17-046455abbb4a (view SPL)Tramadol Hydrochloride Tablets,USP50mgprescriptionHuman PrescriptionApotheca, Increlabel2013-08-131126340786
76e35d447b-341e-4a3f-a18b-fa51f43098ca (view SPL)TRAMADOL HYDROCHLORIDE - Tramadol Hydrochloride Tablets, USP, FULL PRESCRIBING INFORMATIONprescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.REPACK2015-04-151687889304
77ee7179b7-6a08-4eeb-a787-5d697b02c4a2 (view SPL)Tramadol Hydrochloride Tablets, USPprescriptionHuman PrescriptionZydus Pharmaceuticals (Usa) Inc.Analysis, Manufacture2014-07-152683820319
78efb84d69-fbc8-43a5-9c27-73fc8b665dd4 (view SPL)Tramadol Hydrochloride Tablets, USPprescriptionHuman PrescriptionMed-Health Pharma, LlcREPACK2012-10-253511380077
79f05e00b3-25d1-4d96-a5d0-f6260b2507ac (view SPL)prescriptionHuman PrescriptionMylan Institutional Inc.2014-07-036510790991
80f4ae0017-5050-4b92-9944-340385152b95 (view SPL)TRAMADOL HYDROCHLORIDEprescriptionHuman PrescriptionDirect Rxrelabel, repack2015-11-053619190229
81f6d34d61-9175-4106-a497-0598b25212fa (view SPL)Tramadol HCl Tabs 50mgprescriptionHuman PrescriptionNcs Healthcare Of Ky, Inc Dba Vangard LabsRELABEL, REPACK2015-05-071006157810
82fabfa59b-d41c-4292-a569-e0461bbbfeb7 (view SPL)Tramadol Hydrochloride Tablets, USPprescriptionHuman PrescriptionRemedyrepack Inc.2013-05-131521250377

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