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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
CAFFEINE; CODEINE PHOSPHATE; BUTALBITAL; ASPIRIN 0023-6010-01  Allergan, Inc.  NDA019429  HUMAN PRESCRIPTION DRUG  NDA 
CODEINE SULFATE 0054-0243-24  West-Ward Pharmaceuticals Corp.  NDA022402  HUMAN PRESCRIPTION DRUG  NDA 
CODEINE SULFATE 0054-0244-24  West-Ward Pharmaceuticals Corp.  NDA022402  HUMAN PRESCRIPTION DRUG  NDA 
CODEINE SULFATE 0054-0244-25  West-Ward Pharmaceuticals Corp.  NDA022402  HUMAN PRESCRIPTION DRUG  NDA 
CODEINE SULFATE 0054-0245-25  West-Ward Pharmaceuticals Corp.  NDA022402  HUMAN PRESCRIPTION DRUG  NDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 0093-0050-01  Teva Pharmaceuticals USA, Inc.  ANDA088627  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 0093-0150-01  Teva Pharmaceuticals USA, Inc.  ANDA088628  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 0093-0150-10  Teva Pharmaceuticals USA, Inc.  ANDA088628  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 0093-0350-01  Teva Pharmaceuticals USA, Inc.  ANDA088629  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 0093-0350-05  Teva Pharmaceuticals USA, Inc.  ANDA088629  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 0093-0350-10  Teva Pharmaceuticals USA, Inc.  ANDA088629  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 0121-0504-00  Pharmaceutical Associates, Inc.  ANDA087508  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 0121-0504-04  Pharmaceutical Associates, Inc.  ANDA087508  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 0121-0504-05  Pharmaceutical Associates, Inc.  ANDA087508  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 0121-0504-12  Pharmaceutical Associates, Inc.  ANDA087508  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 0121-0504-16  Pharmaceutical Associates, Inc.  ANDA087508  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE 0121-0547-05  Pharmaceutical Associates, Inc.  ANDA089647  HUMAN PRESCRIPTION DRUG  ANDA 
GUAIFENESIN; CODEINE PHOSPHATE 0121-0775-04  Pharmaceutical Associates, Inc.  part341  HUMAN OTC DRUG  OTC monograph final 
GUAIFENESIN; CODEINE PHOSPHATE 0121-0775-08  Pharmaceutical Associates, Inc.  part341  HUMAN OTC DRUG  OTC monograph final 
GUAIFENESIN; CODEINE PHOSPHATE 0121-0775-16  Pharmaceutical Associates, Inc.  part341  HUMAN OTC DRUG  OTC monograph final 
PHENYLEPHRINE HYDROCHLORIDE; CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE 0121-0925-16  Pharmaceutical Associates, Inc.  ANDA040660  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE 0121-0928-16  Pharmaceutical Associates, Inc.  ANDA040650  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 0121-1008-00  Pharmaceutical Associates, Inc.  ANDA087508  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 0121-1008-12  Pharmaceutical Associates, Inc.  ANDA087508  HUMAN PRESCRIPTION DRUG  ANDA 
GUAIFENESIN; CODEINE PHOSPHATE 0121-1550-00  Pharmaceutical Associates, Inc.  part341  HUMAN OTC DRUG  OTC monograph final 
GUAIFENESIN; CODEINE PHOSPHATE 0121-1550-10  Pharmaceutical Associates, Inc.  part341  HUMAN OTC DRUG  OTC monograph final 
GUAIFENESIN; CODEINE PHOSPHATE 0121-1775-00  Pharmaceutical Associates, Inc.  part341  HUMAN OTC DRUG  OTC monograph final 
GUAIFENESIN; CODEINE PHOSPHATE 0121-1775-05  Pharmaceutical Associates, Inc.  part341  HUMAN OTC DRUG  OTC monograph final 
GUAIFENESIN; CODEINE PHOSPHATE 0121-1775-10  Pharmaceutical Associates, Inc.  part341  HUMAN OTC DRUG  OTC monograph final 
ACETAMINOPHEN; CODEINE PHOSPHATE 0406-0483-01  SpecGx LLC  ANDA040419  HUMAN PRESCRIPTION DRUG  ANDA 
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
601-630 631-660 661-690 691-720 721-750 751-780 781-810 811-840 841-867

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