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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 50090-0423-0  A-S Medication Solutions  part341  HUMAN OTC DRUG  OTC MONOGRAPH FINAL 
CODEINE PHOSPHATE; CHLORPHENIRAMINE MALEATE 43378-106-08  codaDOSE Incorporated  part341  HUMAN OTC DRUG  OTC monograph final 
GUAIFENESIN; CODEINE PHOSPHATE 54932-208-81  BioRamo, 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 
CODEINE PHOSPHATE; CHLORPHENIRAMINE MALEATE 43378-100-04  codaDOSE Incorporated  part341  HUMAN OTC DRUG  OTC monograph final 
GUAIFENESIN; CODEINE PHOSPHATE 21695-421-04  Rebel Distributors Corp.  part341  HUMAN OTC DRUG  OTC monograph final 
GUAIFENESIN; CODEINE PHOSPHATE 0121-1775-10  Pharmaceutical Associates, Inc.  part341  HUMAN OTC DRUG  OTC monograph final 
GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE; CODEINE PHOSPHATE 70147-414-16  Glendale Inc  part341  HUMAN OTC DRUG  OTC MONOGRAPH FINAL 
GUAIFENESIN; CODEINE PHOSPHATE 54932-208-85  BioRamo, LLC  part341  HUMAN OTC DRUG  OTC MONOGRAPH FINAL 
ACETAMINOPHEN; CODEINE PHOSPHATE 52959-003-25  H.J. Harkins Company, Inc.  ANDA089805  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 21695-242-30  Rebel Distributors Corp.  ANDA040419  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 54569-0025-1  A-S Medication Solutions LLC  ANDA089805  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 12634-526-40  Apotheca, Inc.  ANDA089805  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CAFFEINE; CODEINE PHOSPHATE; BUTALBITAL 68258-2012-9  Dispensing Solutions, Inc.  ANDA076560  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 33261-001-14  Aidarex Pharmaceuticals LLC  ANDA089805  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 71335-0545-3  Bryant Ranch Prepack  ANDA040779  HUMAN PRESCRIPTION DRUG  ANDA 
CAFFEINE; CODEINE PHOSPHATE; BUTALBITAL; ASPIRIN 63629-2952-2  Bryant Ranch Prepack  ANDA075231  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 54569-1001-0  A-S Medication Solutions LLC  ANDA087508  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 49999-060-50  Lake Erie Medical DBA Quality Care Products LLC  ANDA040419  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 71335-0336-5  Bryant Ranch Prepack  ANDA202800  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 67046-903-21  Contract Pharmacy Services-PA  ANDA088628  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 68071-4533-4  NuCare Pharmaceuticals,Inc.  ANDA040419  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 33261-002-14  Aidarex Pharmaceuticals LLC  ANDA089828  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 68071-4475-4  NuCare Pharmaceuticals,Inc.  ANDA040419  HUMAN PRESCRIPTION DRUG  ANDA 
CAFFEINE; CODEINE PHOSPHATE; BUTALBITAL; ASPIRIN 0527-1312-01  Lannett Company, Inc.  ANDA074951  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 63187-106-30  Proficient Rx LP  ANDA040419  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 71610-111-60  Aphena Pharma Solutions - Tennessee, LLC  ANDA040419  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 53002-0101-5  RPK Pharmaceuticals, Inc.  ANDA040779  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 66336-059-15  Dispensing Solutions, Inc.  ANDA089805  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 52959-003-02  H.J. Harkins Company, Inc.  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
601-630 631-660 661-690 691-720 721-750 751-780 781-810 811-840 841-854

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