Codeine / Promethazine Oral Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Actavis Pharma, Inc. (2012-01-01)
Oldest Current Product
1984-10-31
License(s)
ANDA
RxNORM
ORAL SOLUTION\CODEINE:PROMETHAZINE
FDAOB
ORAL\SYRUP\CODEINE PHOSPHATE: PHENYLEPHRINE HYDROCHLORIDE: PROMETHAZINE HYDROCHLORIDE
ORAL\SYRUP\CODEINE PHOSPHATE: PROMETHAZINE HYDROCHLORIDE
SPL Active
ORAL\LIQUID\CODEINE PHOSPHATE: PROMETHAZINE HYDROCHLORIDE
ORAL\SYRUP\CODEINE PHOSPHATE: PROMETHAZINE HYDROCHLORIDE
SPL Moiety
ORAL\LIQUID\CODEINE: PROMETHAZINE
ORAL\SYRUP\CODEINE ANHYDROUS: PROMETHAZINE
ORAL\SYRUP\CODEINE: PROMETHAZINE

product(s) by strength(s)

codeine phosphate 2 mg/ml / promethazine hydrochloride 1.25 mg/ml oral solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004721627ANDAActavis Pharma, Inc.2003-01-03CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDEORALSYRUPANDA088763a0bcb8ab-089d-449f-9bd6-7857d64e1692
2006031585ANDAQualitest Pharmaceuticals2006-01-31CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDEORALSYRUPANDA040650c6617697-a292-40ba-93c4-65b982715b33
3278080065ANDATris Pharma Inc2013-05-15CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDEORALSYRUPANDA200386785c605e-1907-4fac-8b69-d504a2076f8e
4503830804ANDAHi-Tech Pharmacal Co., Inc.1997-08-26CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDEORALSYRUPANDA040151168951c0-773d-4f3d-9745-cc6de2063b61
5576640185ANDACaraco Pharmaceutical Laboratories, Ltd.2010-03-17CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDEORALSYRUPANDA0901801ada506d-bc8e-4455-9cdc-03433fd77bb5
6604320606ANDAMorton Grove Pharmaceuticals, Inc.1984-12-17CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDEORALSYRUPANDA088875eb9ac8c2-ee04-4eed-9b0e-a25d46a7a044

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001210547ANDAPharmaceutical Associates, Inc.1988-12-22CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDEORALSYRUPANDA089647a5215931-3385-4d8e-b121-47aa1c20420c

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1126340907ANDAApotheca, Inc2012-02-16CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDEORALSYRUP576640185ANDA09018068639fd1-3fd5-4459-8018-51f136e3ed37
2126340908ANDAApotheca, Inc2010-01-01CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDEORALLIQUID604320606ANDA08887547d4eb4f-6dd4-44b9-aea1-19c4bfc1d425
3126340909ANDAApotheca, Inc2009-06-01CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDEORALLIQUID503830804ANDA04015147d4eb4f-6dd4-44b9-aea1-19c4bfc1d425
4178560804ANDAAtlantic Biologicals Corps1997-08-26CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDEORALSYRUP503830804ANDA0401515eafbdbe-58f1-4f2c-a12f-7a5d924e5fff
5178561585ANDAAtlantic Biologicals Corps2006-01-31CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDEORALSYRUP006031585ANDA0406504e0d550e-6281-48ce-819f-ca37fcca53e0
6216950336ANDARebel Distributors Corp2006-01-31CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDEORALSYRUP006031585ANDA0406509408d9fa-ab74-4513-86bc-1f3d6d0dcf9a
7332610391ANDAAidarex Pharmaceuticals Llc2006-01-31CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDEORALSYRUP006031585ANDA0406503150fc52-6a33-42f6-b08a-266146661a5f
8422540140ANDARebel Distributors Corp1984-10-31CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDEORALSYRUP004721627ANDA088763a4fd8978-2036-43cb-ab16-b0dd98d6cd5b
9499990152ANDALake Erie Medical Dba Quality Care Products Llc2012-03-21CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDEORALSYRUP006031585ANDA0406509e62a7f5-c774-444b-b0cb-da800d2f3f7c
10500901482ANDAA-S Medication Solutions Llc2010-03-17CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDEORALSYRUP576640185ANDA090180d2de01f9-ff2b-40b7-82a6-72c47e8e777c
11521250587ANDARemedyrepack Inc.2013-06-04CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDEORALSYRUP503830804ANDA040151f1ac200f-208b-4d6a-a89e-565d8b0d7c0e
12521250596ANDARemedyrepack Inc.2013-07-08CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDEORALSYRUP004721627ANDA0887639a375d70-997f-4310-9829-db3be50da29e
13545691056ANDAA-S Medication Solutions Llc2006-01-31CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDEORALSYRUP006031585ANDA04065098fff598-835c-4efb-b10a-e975dd12f1de
14548681029ANDAPhysicians Total Care, Inc.2001-02-13CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDEORALSYRUP006031585ANDA0406500505fe62-ac59-475e-8c94-1933398be580
15631870271ANDAProficient Rx Lp2006-01-31CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDEORALSYRUP006031585ANDA04065053e98254-eef0-4422-9891-013bd6ecb38a
16636291607ANDABryant Ranch Prepack2003-01-03CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDEORALSYRUP004721627ANDA0887634e2dc369-6fd8-4f7e-951d-ec62d93f84f9
17687889385ANDAPreferred Pharmaceuticals, Inc.2014-07-22CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDEORALSYRUP576640185ANDA09018009442938-34d5-495f-8833-73cf1e7131c9
18687889895ANDAPreferred Pharmaceuticals, Inc.2012-02-14CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDEORALSYRUP006031585ANDA040650164046da-3953-437b-bc8e-a8cb0465f616

application(s)

#idtitledeprecatedapplicantapprovedapproved drugin other drug docs
1ANDA040151PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATEHI TECH PHARMACAL CO INC1997-08-26ANDA040151_001
2ANDA040650PROMETHAZINE WITH CODEINEVINTAGE PHARMACEUTICALS LLC2006-01-31ANDA040650_001
3ANDA088739PHERAZINE W/ CODEINETrueHALSEY DRUG CO INC1988-12-23ANDA088739_001
4ANDA088763PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATEACTAVIS MID ATLANTIC LLC1984-10-31ANDA088763_001
5ANDA088814PROMETHAZINE W/ CODEINETrueHR CENCI LABORATORIES INC1985-11-22ANDA088814_001
6ANDA088875PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATEWOCKHARDT EU OPERATIONS (SWISS) AG1984-12-17ANDA088875_001
7ANDA089647PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATETruePHARMACEUTICAL ASSOC INC DIV BEACH PRODUCTS1988-12-22ANDA089647_001
8ANDA090180PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATESUN PHARMACEUTICAL INDUSTRIES INC2010-03-17ANDA090180_001
9ANDA200386PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATETRIS PHARMA INC2012-06-29ANDA200386_001
10ANDA200894PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATEAMNEAL PHARMACEUTICALS2013-04-24ANDA200894_001
11NDA008306PHENERGAN VC W/ CODEINETrueANI PHARMACEUTICALS INC1984-04-02NDA008306_004, NDA008306_005Codeine / Phenylephrine / Promethazine Oral Solution

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA040151_001RXPROMETHAZINE HYDROCHLORIDE (6.25MG/5ML), CODEINE PHOSPHATE (10MG/5ML)ORALSYRUPFalseAA1997-08-26PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE
2ANDA040650_001RXPROMETHAZINE HYDROCHLORIDE (6.25MG/5ML), CODEINE PHOSPHATE (10MG/5ML)ORALSYRUPFalseAA2006-01-31PROMETHAZINE WITH CODEINE
3ANDA088739_001discontinuedCODEINE PHOSPHATE (10MG/5ML), PROMETHAZINE HYDROCHLORIDE (6.25MG/5ML)ORALSYRUPFalse1988-12-23PHERAZINE W/ CODEINE
4ANDA088763_001RXCODEINE PHOSPHATE (10MG/5ML), PROMETHAZINE HYDROCHLORIDE (6.25MG/5ML)ORALSYRUPTrueAA1984-10-31PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE
5ANDA088814_001discontinuedCODEINE PHOSPHATE (10MG/5ML), PROMETHAZINE HYDROCHLORIDE (6.25MG/5ML)ORALSYRUPFalse1985-11-22PROMETHAZINE W/ CODEINE
6ANDA088875_001RXPROMETHAZINE HYDROCHLORIDE (6.25MG/5ML), CODEINE PHOSPHATE (10MG/5ML)ORALSYRUPFalseAA1984-12-17PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE
7ANDA089647_001discontinuedCODEINE PHOSPHATE (10MG/5ML), PROMETHAZINE HYDROCHLORIDE (6.25MG/5ML)ORALSYRUPFalse1988-12-22PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE
8ANDA090180_001RXCODEINE PHOSPHATE (10MG/5ML), PROMETHAZINE HYDROCHLORIDE (6.25MG/5ML)ORALSYRUPFalseAA2010-03-17PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE
9ANDA200386_001RXCODEINE PHOSPHATE (10MG/5ML), PROMETHAZINE HYDROCHLORIDE (6.25MG/5ML)ORALSYRUPFalseAA2012-06-29PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE
10ANDA200894_001RXPROMETHAZINE HYDROCHLORIDE (6.25MG/5ML), CODEINE PHOSPHATE (10MG/5ML)ORALSYRUPFalseAA2013-04-24PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE
11NDA008306_004discontinuedCODEINE PHOSPHATE (10MG/5ML), PROMETHAZINE HYDROCHLORIDE (6.25MG/5ML)ORALSYRUPFalse1984-04-02PHENERGAN VC W/ CODEINE
12NDA008306_005discontinuedPHENYLEPHRINE HYDROCHLORIDE (5MG/5ML), PROMETHAZINE HYDROCHLORIDE (6.25MG/5ML), CODEINE PHOSPHATE (10MG/5ML)ORALSYRUPFalse1984-04-02PHENERGAN VC W/ CODEINE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
10505fe62-ac59-475e-8c94-1933398be580 (view SPL)PROMETHAZINE WITH CODEINE SYRUP (PROMETHAZINE HYDROCHLORIDE, USP AND CODEINE PHOSPHATE, USP)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2009-08-271548681029
209442938-34d5-495f-8833-73cf1e7131c9 (view SPL)Promethazine Hydrochloride and Codeine Phosphate Syrup 6.25 mg and 10mg/5 mL Rx Only CVprescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.RELABEL2014-07-301687889385
3164046da-3953-437b-bc8e-a8cb0465f616 (view SPL)PROMETHAZINE WITH CODEINE SYRUP (PROMETHAZINE HYDROCHLORIDE, USP AND CODEINE PHOSPHATE, USP)prescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.RELABEL2013-07-102687889895
4168951c0-773d-4f3d-9745-cc6de2063b61 (view SPL)PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUPprescriptionHuman PrescriptionHi-Tech Pharmacal Co., Inc.MANUFACTURE2015-06-2212503830804
51ada506d-bc8e-4455-9cdc-03433fd77bb5 (view SPL)Promethazine Hydrochloride and Codeine Phosphate Syrup 6.25 mg and 10mg/5 mLRx Only CVprescriptionHuman PrescriptionCaraco Pharmaceutical Laboratories, Ltd.ANALYSIS, MANUFACTURE, PACK2015-08-277576640185
63150fc52-6a33-42f6-b08a-266146661a5f (view SPL)PROMETHAZINE WITH CODEINE SYRUP (PROMETHAZINE HYDROCHLORIDE, USP AND CODEINE PHOSPHATE, USP)prescriptionHuman PrescriptionAidarex Pharmaceuticals Llc2014-01-291332610391
747d4eb4f-6dd4-44b9-aea1-19c4bfc1d425 (view SPL)PROMETHAZINE HCI AND CODEINE PHOSPHATE 6.25MG/10MG PER 5ML RX ONLYprescriptionHuman PrescriptionApotheca, Inc2010-03-091126340908, 126340909
84e0d550e-6281-48ce-819f-ca37fcca53e0 (view SPL)PROMETHAZINE WITH CODEINE SYRUP (PROMETHAZINE HYDROCHLORIDE, USP AND CODEINE PHOSPHATE, USP)prescriptionHuman PrescriptionAtlantic Biologicals CorpsRELABEL, REPACK2013-03-052178561585
94e2dc369-6fd8-4f7e-951d-ec62d93f84f9 (view SPL)PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUPprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2014-07-181000636291607
1053e98254-eef0-4422-9891-013bd6ecb38a (view SPL)PROMETHAZINE WITH CODEINE SYRUP (PROMETHAZINE HYDROCHLORIDE, USP AND CODEINE PHOSPHATE, USP)prescriptionHuman PrescriptionProficient Rx LpRELABEL, REPACK2014-11-011631870271
115eafbdbe-58f1-4f2c-a12f-7a5d924e5fff (view SPL)PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUPprescriptionHuman PrescriptionAtlantic Biologicals CorpsRELABEL, REPACK2012-04-132178560804
1268639fd1-3fd5-4459-8018-51f136e3ed37 (view SPL)Promethazine Hydrochloride and Codeine Phosphate Syrup 6.25 mg and 10mg/5 mLRx Only CVprescriptionHuman PrescriptionApotheca, Increpack2013-10-072126340907
13785c605e-1907-4fac-8b69-d504a2076f8e (view SPL)Promethazine Hydrochloride and Codeine Phosphate SyrupprescriptionHuman PrescriptionTris Pharma IncANALYSIS, API MANUFACTURE, MANUFACTURE2013-02-214278080065
149408d9fa-ab74-4513-86bc-1f3d6d0dcf9a (view SPL)PROMETHAZINE WITH CODEINE SYRUP (PROMETHAZINE HYDROCHLORIDE, USP AND CODEINE PHOSPHATE, USP)prescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2010-11-112216950336
1598fff598-835c-4efb-b10a-e975dd12f1de (view SPL)PROMETHAZINE WITH CODEINE SYRUP (PROMETHAZINE HYDROCHLORIDE, USP AND CODEINE PHOSPHATE, USP)prescriptionHuman PrescriptionA-S Medication Solutions Llcrelabel2013-05-011545691056
169a375d70-997f-4310-9829-db3be50da29e (view SPL)PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUPprescriptionHuman PrescriptionRemedyrepack Inc.2013-07-082521250596
179e62a7f5-c774-444b-b0cb-da800d2f3f7c (view SPL)PROMETHAZINE WITH CODEINE SYRUP (PROMETHAZINE HYDROCHLORIDE, USP AND CODEINE PHOSPHATE, USP)prescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrelabel, repack2012-03-213688499990152
18a0bcb8ab-089d-449f-9bd6-7857d64e1692 (view SPL)PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUPprescriptionHuman PrescriptionActavis Pharma, Inc.MANUFACTURE2012-01-013004721627
19a4fd8978-2036-43cb-ab16-b0dd98d6cd5b (view SPL)PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP CV FORM NO. 1627 Rev. 1/09 VC3276 Rx OnlyprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2012-01-241422540140
20a5215931-3385-4d8e-b121-47aa1c20420c (view SPL)PROMETHAZINE HCL AND CODEINE PHOSPHATE SYRUP CVprescriptionHuman PrescriptionPharmaceutical Associates, Inc.MANUFACTURE2013-03-212001210547
21c6617697-a292-40ba-93c4-65b982715b33 (view SPL)PROMETHAZINE WITH CODEINE SYRUP (PROMETHAZINE HYDROCHLORIDE, USP AND CODEINE PHOSPHATE, USP)prescriptionHuman PrescriptionQualitest PharmaceuticalsMANUFACTURE2015-02-056006031585
22d2de01f9-ff2b-40b7-82a6-72c47e8e777c (view SPL)Promethazine Hydrochloride and Codeine Phosphate Syrup 6.25 mg and 10mg/5 mLRx Only CVprescriptionHuman PrescriptionA-S Medication Solutions Llcrelabel2014-12-151500901482
23eb9ac8c2-ee04-4eed-9b0e-a25d46a7a044 (view SPL)PROMETHAZINE AND CODEINEPromethazine Hydrochloride and CodeinePhosphate Syrup CVprescriptionHuman PrescriptionMorton Grove Pharmaceuticals, Inc.2013-05-284604320606
24f1ac200f-208b-4d6a-a89e-565d8b0d7c0e (view SPL)PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUPprescriptionHuman PrescriptionRemedyrepack Inc.2013-06-041521250587

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