Acetaminophen / Codeine Oral Suspension

Brand(s)
Capital and Codeine
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Valeant Pharmaceuticals North America Llc (2014-10-03)
Oldest Current Product
2004-05-03
License(s)
ANDA
RxNORM
ORAL SUSPENSION\ACETAMINOPHEN:CODEINE
FDAOB
ORAL\SUSPENSION\ACETAMINOPHEN: CODEINE PHOSPHATE
SPL Active
ORAL\SUSPENSION\ACETAMINOPHEN: CODEINE PHOSPHATE
SPL Moiety
ORAL\SUSPENSION\ACETAMINOPHEN: CODEINE ANHYDROUS

product(s) by strength(s)

acetaminophen 24 mg/ml / codeine phosphate 2.4 mg/ml oral suspension

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001870003Capital and CodeineANDAValeant Pharmaceuticals North America Llc2004-05-03ACETAMINOPHEN, CODEINE PHOSPHATEORALSUSPENSIONANDA08602456879e9f-f5ab-4ea6-a50b-e5e6f5db5a9b

application(s)

#idtitledeprecatedapplicantapproved drug
1ANDA085883CAPITAL AND CODEINETrueACTAVIS MID ATLANTIC LLCANDA085883_001
2ANDA086024CAPITAL AND CODEINEVALEANT PHARMACEUTICALS NORTH AMERICA LLCANDA086024_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapplication
1ANDA085883_001discontinuedCODEINE PHOSPHATE (12MG/5ML), ACETAMINOPHEN (120MG/5ML)ORALSUSPENSIONFalseCAPITAL AND CODEINE
2ANDA086024_001RXCODEINE PHOSPHATE (12MG/5ML), ACETAMINOPHEN (120MG/5ML)ORALSUSPENSIONTrueCAPITAL AND CODEINE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
156879e9f-f5ab-4ea6-a50b-e5e6f5db5a9b (view SPL)CAPITAL AND CODEINE ORAL SUSPENSION (ACETAMINOPHEN AND CODEINE PHOSPHATE ORAL SUSPENSION USP) CV NON-ALCOHOLICprescriptionHuman PrescriptionValeant Pharmaceuticals North America LlcMANUFACTURE2014-10-0310001870003

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