Codeine / Phenylephrine / Promethazine Oral Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Actavis Pharma, Inc. (2013-02-28)
Oldest Current Product
1999-03-01
License(s)
ANDA
RxNORM
ORAL SOLUTION\CODEINE:PHENYLEPHRINE:PROMETHAZINE
FDAOB
ORAL\SYRUP\CODEINE PHOSPHATE: PHENYLEPHRINE HYDROCHLORIDE: PROMETHAZINE HYDROCHLORIDE
ORAL\SYRUP\CODEINE PHOSPHATE: PROMETHAZINE HYDROCHLORIDE
SPL Active
ORAL\SYRUP\CODEINE PHOSPHATE: PHENYLEPHRINE HYDROCHLORIDE: PROMETHAZINE HYDROCHLORIDE
SPL Moiety
ORAL\SYRUP\CODEINE ANHYDROUS: PHENYLEPHRINE: PROMETHAZINE
ORAL\SYRUP\CODEINE: PHENYLEPHRINE: PROMETHAZINE

product(s) by strength(s)

codeine phosphate 2 mg/ml / phenylephrine hydrochloride 1 mg/ml / promethazine hydrochloride 1.25 mg/ml oral solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004721629ANDAActavis Pharma, Inc.2011-12-19CODEINE PHOSPHATE, PHENYLEPHRINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDEORALSYRUPANDA088764af510f62-8a92-439e-86d3-f7fc797476b3
2006031588ANDAQualitest Pharmaceuticals2006-12-07CODEINE PHOSPHATE, PHENYLEPHRINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDEORALSYRUPANDA040660f6e9148b-52a9-46e9-ba50-7757215754d7
3503830805ANDAHi-Tech Pharmacal Co., Inc.2015-06-16CODEINE PHOSPHATE, PHENYLEPHRINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDEORALSYRUPANDA0406743f40cef0-431c-4728-9a91-10720b16de55
4651620694ANDAAmneal Pharmaceuticals2013-11-01CODEINE PHOSPHATE, PHENYLEPHRINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDEORALSYRUPANDA2009635f23b254-872b-4e88-91be-710c3ea7687b

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1500900223ANDAA-S Medication Solutions Llc2006-12-07CODEINE PHOSPHATE, PHENYLEPHRINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDEORALSYRUP006031588ANDA040660c09ba689-4377-4946-b8b0-5f64d5e90d07
2545691047ANDAA-S Medication Solutions Llc2006-12-07CODEINE PHOSPHATE, PHENYLEPHRINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDEORALSYRUP006031588ANDA040660d83a7bac-ace9-4692-afff-e11b7b0510c1
3548680263ANDAPhysicians Total Care, Inc.1999-03-01CODEINE PHOSPHATE, PHENYLEPHRINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDEORALSYRUP006031588ANDA040660b21f10fb-0ced-4e57-b74f-0c9211491c1e
4550451266ANDADispensing Solutions, Inc.2006-12-07CODEINE PHOSPHATE, PHENYLEPHRINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDEORALSYRUP006031588ANDA0406605c3c2c1b-ab52-410b-8c94-c125c6adb4d2
5636292959ANDABryant Ranch Prepack2011-12-19CODEINE PHOSPHATE, PHENYLEPHRINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDEORALSYRUP004721629ANDA0887647095b0c4-9759-4e27-96d6-823a8ce6521c

application(s)

#idtitledeprecatedapplicantapprovedapproved drugin other drug docs
1ANDA040660PROMETH HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATEVINTAGE PHARMACEUTICALS LLC2006-12-07ANDA040660_001
2ANDA040674PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATEHI-TECH PHARMACAL CO INC2014-12-23ANDA040674_001
3ANDA088764PROMETH VC W/ CODEINEACTAVIS MID ATLANTIC LLC1984-10-31ANDA088764_001
4ANDA088816PROMETHAZINE VC W/ CODEINETrueHR CENCI LABORATORIES INC1985-11-22ANDA088816_001
5ANDA088870PHERAZINE VC W/ CODEINETrueHALSEY DRUG CO INC1987-03-02ANDA088870_001
6ANDA088896PROMETHAZINE VC W/ CODEINETrueWOCKHARDT EU OPERATIONS (SWISS) AG1985-01-04ANDA088896_001
7ANDA200963PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATEAMNEAL PHARMACEUTICALS2015-08-26ANDA200963_001
8NDA008306PHENERGAN VC W/ CODEINETrueANI PHARMACEUTICALS INC1984-04-02NDA008306_004, NDA008306_005Codeine / Promethazine Oral Solution

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA040660_001RXCODEINE PHOSPHATE (10MG/5ML), PROMETHAZINE HYDROCHLORIDE (6.25MG/5ML), PHENYLEPHRINE HYDROCHLORIDE (5MG/5ML)ORALSYRUPFalseAA2006-12-07PROMETH HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE
2ANDA040674_001RXPHENYLEPHRINE HYDROCHLORIDE (5MG/5ML), PROMETHAZINE HYDROCHLORIDE (6.25MG/5ML), CODEINE PHOSPHATE (10MG/5ML)ORALSYRUPFalseAA2014-12-23PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE
3ANDA088764_001RXCODEINE PHOSPHATE (10MG/5ML), PHENYLEPHRINE HYDROCHLORIDE (5MG/5ML), PROMETHAZINE HYDROCHLORIDE (6.25MG/5ML)ORALSYRUPTrueAA1984-10-31PROMETH VC W/ CODEINE
4ANDA088816_001discontinuedPHENYLEPHRINE HYDROCHLORIDE (5MG/5ML), PROMETHAZINE HYDROCHLORIDE (6.25MG/5ML), CODEINE PHOSPHATE (10MG/5ML)ORALSYRUPFalse1985-11-22PROMETHAZINE VC W/ CODEINE
5ANDA088870_001discontinuedPROMETHAZINE HYDROCHLORIDE (6.25MG/5ML), PHENYLEPHRINE HYDROCHLORIDE (5MG/5ML), CODEINE PHOSPHATE (10MG/5ML)ORALSYRUPFalse1987-03-02PHERAZINE VC W/ CODEINE
6ANDA088896_001discontinuedPHENYLEPHRINE HYDROCHLORIDE (5MG/5ML), CODEINE PHOSPHATE (10MG/5ML), PROMETHAZINE HYDROCHLORIDE (6.25MG/5ML)ORALSYRUPFalse1985-01-04PROMETHAZINE VC W/ CODEINE
7ANDA200963_001RXPROMETHAZINE HYDROCHLORIDE (6.25MG/5ML), CODEINE PHOSPHATE (10MG/5ML), PHENYLEPHRINE HYDROCHLORIDE (5MG/5ML)ORALSYRUPFalseAA2015-08-26PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE
8NDA008306_004discontinuedCODEINE PHOSPHATE (10MG/5ML), PROMETHAZINE HYDROCHLORIDE (6.25MG/5ML)ORALSYRUPFalse1984-04-02PHENERGAN VC W/ CODEINE
9NDA008306_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)
13f40cef0-431c-4728-9a91-10720b16de55 (view SPL)PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE, AND CODEINE PHOSPHATE SYRUPprescriptionHuman PrescriptionHi-Tech Pharmacal Co., Inc.MANUFACTURE2015-06-083503830805
25c3c2c1b-ab52-410b-8c94-c125c6adb4d2 (view SPL)PROMETHAZINE VC WITH CODEINE SYRUP (PROMETHAZINE HYDROCHLORIDE, USP, PHENYLEPHRINE HYDROCHLORIDE, USP AND CODEINE PHOSPHATE, USP)prescriptionHuman PrescriptionDispensing Solutions, Inc.relabel, repack2011-10-071550451266
35f23b254-872b-4e88-91be-710c3ea7687b (view SPL)PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP, USPCV Rx OnlyprescriptionHuman PrescriptionAmneal PharmaceuticalsANALYSIS, LABEL, MANUFACTURE, PACK2015-09-3010651620694
47095b0c4-9759-4e27-96d6-823a8ce6521c (view SPL)PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUPprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2013-04-251000636292959
5af510f62-8a92-439e-86d3-f7fc797476b3 (view SPL)PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP C-VprescriptionHuman PrescriptionActavis Pharma, Inc.ANALYSIS, MANUFACTURE, PACK2013-02-283004721629
6b21f10fb-0ced-4e57-b74f-0c9211491c1e (view SPL)PROMETHAZINE VC WITH CODEINE SYRUP (PROMETHAZINE HYDROCHLORIDE, USP, PHENYLEPHRINE HYDROCHLORIDE, USP AND CODEINE PHOSPHATE, USP)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2011-06-102548680263
7c09ba689-4377-4946-b8b0-5f64d5e90d07 (view SPL)PROMETHAZINE VC WITH CODEINE SYRUP (PROMETHAZINE HYDROCHLORIDE, USP, PHENYLEPHRINE HYDROCHLORIDE, USP AND CODEINE PHOSPHATE, USP)prescriptionHuman PrescriptionA-S Medication Solutions Llcrelabel2014-12-141500900223
8d83a7bac-ace9-4692-afff-e11b7b0510c1 (view SPL)PROMETHAZINE VC WITH CODEINE SYRUP (PROMETHAZINE HYDROCHLORIDE, USP, PHENYLEPHRINE HYDROCHLORIDE, USP AND CODEINE PHOSPHATE, USP)prescriptionHuman PrescriptionA-S Medication Solutions Llcrelabel2013-05-011545691047
9f6e9148b-52a9-46e9-ba50-7757215754d7 (view SPL)PROMETHAZINE VC WITH CODEINE SYRUP (PROMETHAZINE HYDROCHLORIDE, USP, PHENYLEPHRINE HYDROCHLORIDE, USP AND CODEINE PHOSPHATE, USP)prescriptionHuman PrescriptionQualitest PharmaceuticalsMANUFACTURE2015-02-0510006031588

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