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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
CODEINE PHOSPHATE; GUAIFENESIN 55154-9627-5  Cardinal Health 107, LLC  part341  HUMAN OTC DRUG  OTC monograph final 
GUAIFENESIN; CODEINE PHOSPHATE 0121-1550-00  Pharmaceutical Associates, Inc.  part341  HUMAN OTC DRUG  OTC monograph final 
PYRILAMINE MALEATE; CODEINE PHOSPHATE 66594-333-16  Pro-Pharma LLC  part341  HUMAN OTC DRUG  OTC monograph final 
GUAIFENESIN; CODEINE PHOSPHATE 57963-103-04  The Generic Pharmaceutical Company  part341  HUMAN OTC DRUG  OTC MONOGRAPH FINAL 
BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE; CODEINE PHOSPHATE 50991-723-16  Poly Pharmaceuticals, Inc.  part341  HUMAN OTC DRUG  OTC monograph final 
GUAIFENESIN; CODEINE PHOSPHATE 58605-313-16  MCR American Pharmaceuticals, Inc.  part341  HUMAN OTC DRUG  OTC MONOGRAPH FINAL 
ACETAMINOPHEN; CODEINE PHOSPHATE 61502-903-97  EPM Packaging Inc  ANDA088627  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE 12634-907-32  Apotheca Inc.  ANDA090180  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CAFFEINE; BUTALBITAL; CODEINE PHOSPHATE 68258-2012-9  Dispensing Solutions, Inc.  ANDA076560  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; ACETAMINOPHEN 33261-001-90  Aidarex Pharmaceuticals LLC  ANDA089805  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 67544-002-80  Aphena Pharma Solutions - Tennessee, LLC  ANDA040419  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 71930-055-12  Eywa Pharma Inc  ANDA211610  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 68387-250-40  Keltman Pharmaceuticals, Inc.  ANDA089805  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 66336-059-10  Dispensing Solutions, Inc.  ANDA089805  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 63304-562-01  Sun Pharmaceutical Industries, Inc.  ANDA085868  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 12634-526-96  Apotheca, Inc.  ANDA089805  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; ACETAMINOPHEN 50090-1935-0  A-S Medication Solutions  ANDA202800  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 21695-242-15  Rebel Distributors Corp.  ANDA040419  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 21695-242-40  Rebel Distributors Corp.  ANDA040419  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE 63629-5637-2  Bryant Ranch Prepack  ANDA204785  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CAFFEINE; CODEINE PHOSPHATE; BUTALBITAL 51991-073-01  Breckenridge Pharmaceutical, Inc.  ANDA076560  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; ACETAMINOPHEN 53489-159-01  Mutual Pharmaceutical Company, Inc.  ANDA089671  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 68788-7859-6  Preferred Pharmaceuticals Inc.  ANDA040419  HUMAN PRESCRIPTION DRUG  ANDA 
PROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE 12634-909-02  Apotheca Inc  ANDA040151  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; ACETAMINOPHEN 68071-4430-5  NuCare Pharmaceuticals,Inc.  ANDA040419  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; ACETAMINOPHEN 67544-882-53  Aphena Pharma Solutions - Tennessee, LLC  ANDA089805  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 63187-470-30  Proficient Rx LP  ANDA089805  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; ACETAMINOPHEN 50383-339-13  Akorn  ANDA040119  HUMAN PRESCRIPTION DRUG  ANDA 
PROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE 12634-909-04  Apotheca Inc  ANDA040151  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE 10191-1045-2  Ethical Nutritional, LLC    HUMAN PRESCRIPTION DRUG  unapproved homeopathic 
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
601-630 631-660 661-690 691-720 721-750 751-755

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