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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 69367-272-16  Westminster Pharmaceuticals, LLC  part341  HUMAN OTC DRUG  OTC MONOGRAPH FINAL 
GUAIFENESIN; CODEINE PHOSPHATE 50383-087-10  Akorn Operating Company LLC  part341  HUMAN OTC DRUG  OTC monograph final 
ACETAMINOPHEN; CODEINE PHOSPHATE 70518-3051-0  REMEDYREPACK INC.  ANDA202800  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 67544-002-20  Aphena Pharma Solutions - Tennessee, LLC  ANDA040419  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 0406-0484-10  SpecGx LLC  ANDA040419  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 68071-4673-4  NuCare Pharmaceuticals,Inc.  ANDA202800  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; ACETAMINOPHEN 63304-561-05  Sun Pharmaceutical Industries, Inc.  ANDA087083  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; ACETAMINOPHEN 10544-100-10  Blenheim Pharmacal, Inc.  ANDA089805  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 67544-002-53  Aphena Pharma Solutions - Tennessee, LLC  ANDA040419  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; ACETAMINOPHEN 67296-1516-6  RedPharm Drug, Inc.  ANDA202800  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE SULFATE 0054-0244-25  Hikma Pharmaceuticals USA Inc.  NDA022402  HUMAN PRESCRIPTION DRUG  NDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 52959-446-90  H.J. Harkins Company, Inc.  ANDA202800  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; ACETAMINOPHEN 13107-060-05  Aurolife Pharma, LLC  ANDA202800  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 49999-060-12  Lake Erie Medical DBA Quality Care Products LLC  ANDA040419  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; ACETAMINOPHEN 53002-0102-3  RPK Pharmaceuticals, Inc.  ANDA040419  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 64850-643-12  Elite Laboratories, Inc.  ANDA212418  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 67544-002-40  Aphena Pharma Solutions - Tennessee, LLC  ANDA040419  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE 12634-909-04  Apotheca Inc  ANDA040151  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 67544-002-55  Aphena Pharma Solutions - Tennessee, LLC  ANDA040419  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 53489-161-02  Mutual Pharmaceutical Company, Inc.  ANDA089673  HUMAN PRESCRIPTION DRUG  ANDA 
CAFFEINE; ACETAMINOPHEN; DIHYDROCODEINE BITARTRATE 63187-705-90  Proficient Rx LP  ANDA204785  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; ACETAMINOPHEN 61919-053-30  Direct_Rx  ANDA202800  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; ACETAMINOPHEN 50383-340-17  Akorn  ANDA040119  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 49999-060-24  Lake Erie Medical DBA Quality Care Products LLC  ANDA040419  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; ACETAMINOPHEN 71610-111-90  Aphena Pharma Solutions - Tennessee, LLC  ANDA040419  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 21695-242-28  Rebel Distributors Corp.  ANDA040419  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 53489-161-01  Mutual Pharmaceutical Company, Inc.  ANDA089673  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; ACETAMINOPHEN 10544-100-15  Blenheim Pharmacal, Inc.  ANDA089805  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE 21695-336-04  Rebel Distributors Corp.  ANDA040650  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 61502-903-97  EPM Packaging Inc  ANDA088627  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
601-630 631-660 661-690 691-720 721-750 751-762

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