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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
PSEUDOEPHEDRINE HYDROCHLORIDE; CODEINE PHOSPHATE; CHLORPHENIRAMINE MALEATE 0603-1520-58  Qualitest Pharmaceuticals  part341  HUMAN OTC DRUG  OTC MONOGRAPH FINAL 
GUAIFENESIN; CODEINE PHOSPHATE 55154-9439-5  Cardinal Health  part341  HUMAN OTC DRUG  OTC monograph final 
GUAIFENESIN; CODEINE PHOSPHATE 0121-1775-00  Pharmaceutical Associates, Inc.  part341  HUMAN OTC DRUG  OTC monograph final 
PSEUDOEPHEDRINE HYDROCHLORIDE; CODEINE PHOSPHATE; BROMPHENIRAMINE MALEATE 0682-0480-16  Marnel Pharmaceutcals, Inc.  part341  HUMAN OTC DRUG  OTC MONOGRAPH FINAL 
PHENYLEPHRINE HYDROCHLORIDE; DEXCHLORPHENIRAMINE MALEATE; CODEINE PHOSPHATE 66594-499-01  Pro-Pharma, LLC  part341  HUMAN OTC DRUG  OTC monograph final 
CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE 53002-3270-1  RPK Pharmaceuticals, Inc.  ANDA040650  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 67544-003-60  Aphena Pharma Solutions - Tennessee, LLC  ANDA040419  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 67046-929-30  Contract Pharmacy Services-PA  ANDA202800  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 63187-815-60  Proficient Rx LP  ANDA202800  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 49999-060-12  Lake Erie Medical DBA Quality Care Products LLC  ANDA040419  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 54868-0072-1  Physicians Total Care, Inc.  ANDA040419  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 63629-3031-2  Bryant Ranch Prepack  ANDA040419  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 33261-001-25  Aidarex Pharmaceuticals LLC  ANDA089805  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 21695-242-40  Rebel Distributors Corp.  ANDA040419  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 67544-882-55  Aphena Pharma Solutions - Tennessee, LLC  ANDA089805  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 55289-005-15  PD-Rx Pharmaceuticals, Inc.  ANDA089805  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 49999-060-15  Lake Erie Medical DBA Quality Care Products LLC  ANDA040419  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 50436-3227-7  Unit Dose Services  ANDA040779  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 0121-1008-12  Pharmaceutical Associates, Inc.  ANDA087508  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 0093-0050-01  Teva Pharmaceuticals USA, Inc.  ANDA088627  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 12634-526-82  Apotheca, Inc.  ANDA089805  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 71335-0256-6  Bryant Ranch Prepack  ANDA202800  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE 10191-1045-2  Remedy Makers    HUMAN PRESCRIPTION DRUG  unapproved homeopathic 
CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE 49999-152-04  Lake Erie Medical DBA Quality Care Products LLC  ANDA040650  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 54569-0302-2  A-S Medication Solutions LLC  ANDA089828  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE 12634-907-04  Apotheca Inc.  ANDA090180  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 68387-250-30  Keltman Pharmaceuticals, Inc.  ANDA089805  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 68788-9506-2  Preferred Pharmaceuticals, Inc.  ANDA040419  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE SULFATE 54868-2541-1  PHYSICIANS TOTAL CARE, INC  NDA022402  HUMAN PRESCRIPTION DRUG  NDA 
PHENYLEPHRINE HYDROCHLORIDE; CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE 50383-805-04  Hi-Tech Pharmacal Co., Inc.  ANDA040674  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
601-630 631-660 661-690 691-720 721-750 751-780 781-789

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