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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
PHENYLEPHRINE HYDROCHLORIDE; CODEINE PHOSPHATE; BROMPHENIRAMINE MALEATE 50991-723-15  Poly Pharmaceuticals, Inc.  part341  HUMAN OTC DRUG  OTC monograph final 
PHENYLEPHRINE HYDROCHLORIDE; CODEINE PHOSPHATE; CHLORPHENIRAMINE MALEATE 29978-420-15  Capital Pharmaceutical, LLC  part341  HUMAN OTC DRUG  OTC monograph final 
GUAIFENESIN; CODEINE PHOSPHATE 61919-110-04  DirectRX  part341  HUMAN OTC DRUG  OTC monograph final 
CODEINE PHOSPHATE; CHLORPHENIRAMINE MALEATE 43378-103-04  codaDOSE Incorporated  part341  HUMAN OTC DRUG  OTC monograph final 
GUAIFENESIN; CODEINE PHOSPHATE 0121-0775-16  Pharmaceutical Associates, Inc.  part341  HUMAN OTC DRUG  OTC monograph final 
GUAIFENESIN; CODEINE PHOSPHATE 69543-276-16  Virtus Pharmaceuticals LLC  part341  HUMAN OTC DRUG  OTC monograph final 
GUAIFENESIN; CODEINE PHOSPHATE 71205-363-04  Proficient Rx LP  part341  HUMAN OTC DRUG  OTC monograph final 
GUAIFENESIN; CODEINE PHOSPHATE 69543-252-16  Virtus Pharmaceuticals  part341  HUMAN OTC DRUG  OTC MONOGRAPH FINAL 
GUAIFENESIN; CODEINE PHOSPHATE 70861-1107-1  Bishop Pharma, LLC  part341  HUMAN OTC DRUG  OTC MONOGRAPH FINAL 
PHENYLEPHRINE HYDROCHLORIDE; CODEINE PHOSPHATE; BROMPHENIRAMINE MALEATE 12830-754-12  R.A. McNeil Company  part341  HUMAN OTC DRUG  OTC monograph final 
ACETAMINOPHEN; CODEINE PHOSPHATE 12634-526-91  Apotheca, Inc.  ANDA089805  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE 12634-907-02  Apotheca Inc.  ANDA090180  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 52959-003-15  H.J. Harkins Company, Inc.  ANDA089805  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 63629-7668-1  Bryant Ranch Prepack  ANDA202800  HUMAN PRESCRIPTION DRUG  ANDA 
CAFFEINE; CODEINE PHOSPHATE; BUTALBITAL; ASPIRIN 0722-6094-05  Nexgen Pharma, Inc.  ANDA075231  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 10544-100-20  Blenheim Pharmacal, Inc.  ANDA089805  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 50090-3011-7  A-S Medication Solutions  ANDA040419  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 45865-466-60  Medsource Pharmaceuticals  ANDA202800  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 68788-9300-6  Preferred Pharmaceuticals, Inc.  ANDA202800  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 54868-0072-7  Physicians Total Care, Inc.  ANDA040419  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 61919-484-90  Direct_Rx  ANDA040419  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CAFFEINE; CODEINE PHOSPHATE; BUTALBITAL 0591-2641-01  Actavis Pharma, Inc.  ANDA076560  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 16590-361-04  STAT RX USA LLC  ANDA087508  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 54569-2523-7  A-S Medication Solutions LLC  ANDA089805  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 53217-370-20  Aidarex Pharmaceuticals LLC  ANDA040419  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 50090-3011-2  A-S Medication Solutions  ANDA040419  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 49999-060-60  Lake Erie Medical DBA Quality Care Products LLC  ANDA040419  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 0121-0504-05  Pharmaceutical Associates, Inc.  ANDA087508  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 33261-001-50  Aidarex Pharmaceuticals LLC  ANDA089805  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 16590-023-75  STAT RX USA LLC  ANDA089805  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
601-630 631-660 661-690 691-720 721-750 751-780 781-790

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