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U.S. Department of Health and Human Services

FDA Application

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NDC Search Results on Active Ingredient: codeine

Click on Active Ingredient to view the label.

Ingredient Name NDC Company Name Application Number or Regulatory Citation Product Type Marketing Category
GUAIFENESIN; CODEINE PHOSPHATE 21695-421-04  Rebel Distributors Corp.  part341  HUMAN OTC DRUG  OTC monograph final 
GUAIFENESIN; CODEINE PHOSPHATE 68071-2472-4  NuCare Pharmaceuticals,Inc.  part341  HUMAN OTC DRUG  OTC monograph final 
GUAIFENESIN; CODEINE PHOSPHATE 68071-2935-4  NuCare Pharmaceuticals,Inc.  part341  HUMAN OTC DRUG  OTC monograph final 
CODEINE PHOSPHATE; GUAIFENESIN 55154-5791-5  Cardinal Health 107, LLC  M012  HUMAN OTC DRUG  OTC Monograph Drug 
CODEINE PHOSPHATE; GUAIFENESIN 54932-208-85  BioRamo, LLC  part341  HUMAN OTC DRUG  OTC MONOGRAPH FINAL 
GUAIFENESIN; CODEINE PHOSPHATE 50383-087-07  Akorn Operating Company LLC  part341  HUMAN OTC DRUG  OTC monograph final 
CODEINE PHOSPHATE; GUAIFENESIN 23359-040-16  Centurion Labs, LLC  part341  HUMAN OTC DRUG  OTC monograph final 
CODEINE PHOSPHATE; GUAIFENESIN 70147-313-16  Glendale Inc  part341  HUMAN OTC DRUG  OTC MONOGRAPH FINAL 
CODEINE PHOSPHATE; GUAIFENESIN 61919-110-04  DirectRX  part341  HUMAN OTC DRUG  OTC monograph final 
GUAIFENESIN; CODEINE PHOSPHATE 57963-103-04  The Generic Pharmaceutical Company  part341  HUMAN OTC DRUG  OTC MONOGRAPH FINAL 
GUAIFENESIN; CODEINE PHOSPHATE 0121-0775-16  PAI Holdings, LLC  M012  HUMAN OTC DRUG  OTC Monograph Drug 
BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE; CODEINE PHOSPHATE 50991-723-15  Poly Pharmaceuticals, Inc.    HUMAN OTC DRUG  unapproved drug other 
CODEINE PHOSPHATE; GUAIFENESIN 70752-177-12  QUAGEN PHARMACEUTICALS LLC  part341  HUMAN OTC DRUG  OTC monograph final 
GUAIFENESIN; CODEINE PHOSPHATE 50383-087-04  Akorn Operating Company LLC  part341  HUMAN OTC DRUG  OTC monograph final 
GUAIFENESIN; CODEINE PHOSPHATE 57963-103-16  The Generic Pharmaceutical Company  part341  HUMAN OTC DRUG  OTC MONOGRAPH FINAL 
CODEINE PHOSPHATE; GUAIFENESIN 63187-117-04  Proficient Rx LP  part341  HUMAN OTC DRUG  OTC monograph final 
GUAIFENESIN; CODEINE PHOSPHATE 58657-500-16  Method Pharmaceuticals, LLC  M012  HUMAN OTC DRUG  OTC Monograph Drug 
DEXCHLORPHENIRAMINE MALEATE; CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE 66594-499-01  Pro-Pharma, LLC  part341  HUMAN OTC DRUG  OTC monograph final 
GUAIFENESIN; CODEINE PHOSPHATE 53002-3191-1  RPK Pharmaceuticals, Inc.  part341  HUMAN OTC DRUG  OTC monograph final 
CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE; CODEINE PHOSPHATE 58605-303-10  MCR American Pharmaceuticals, Inc.  part341  HUMAN OTC DRUG  OTC monograph final 
GUAIFENESIN; CODEINE PHOSPHATE 50383-087-12  Akorn Operating Company LLC  part341  HUMAN OTC DRUG  OTC monograph final 
GUAIFENESIN; CODEINE PHOSPHATE 17856-0208-1  ATLANTIC BIOLOGICALS CORP.  part341  HUMAN OTC DRUG  OTC MONOGRAPH FINAL 
GUAIFENESIN; CODEINE PHOSPHATE; PSEUDOEPHEDRINE HYDROCHLORIDE 43378-124-08  codaDOSE Incorporated  part341  HUMAN OTC DRUG  OTC monograph final 
CODEINE PHOSPHATE; BROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE 23359-023-16  Centurion Labs, LLC  part341  HUMAN OTC DRUG  OTC monograph final 
PSEUDOEPHEDRINE; CODEINE PHOSPHATE; GUAIFENESIN 43378-126-08  codaDOSE Incorporated  part341  HUMAN OTC DRUG  OTC monograph final 
CODEINE PHOSPHATE; PSEUDOEPHEDRINE HYDROCHLORIDE; GUAIFENESIN 43378-121-04  codaDOSE Incorporated  part341  HUMAN OTC DRUG  OTC monograph final 
PYRILAMINE MALEATE; CODEINE PHOSPHATE 66594-333-01  Pro-Pharma LLC  part341  HUMAN OTC DRUG  OTC monograph final 
CODEINE PHOSPHATE; GUAIFENESIN 70752-177-06  QUAGEN PHARMACEUTICALS LLC  part341  HUMAN OTC DRUG  OTC monograph final 
PSEUDOEPHEDRINE HYDROCHLORIDE; CODEINE PHOSPHATE; CHLORPHENIRAMINE MALEATE 60575-313-16  Respa Pharmaceuticals, Inc  part341  HUMAN OTC DRUG  OTC monograph final 
GUAIFENESIN; CODEINE PHOSPHATE 72162-1669-2  Bryant Ranch Prepack  M012  HUMAN OTC DRUG  OTC Monograph Drug 
1-30 31-60 61-90 91-120 121-150 151-180 181-210 211-240 241-270 271-300
301-330 331-360 361-390 391-420 421-450 451-480 481-510 511-540 541-570 571-600
601-630 631-660 661-690 691-720 721-750 751-753

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