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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; ACETAMINOPHEN 50383-338-11  Akorn  ANDA040119  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 52959-003-04  H.J. Harkins Company, Inc.  ANDA089805  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; ACETAMINOPHEN 49999-026-60  Quality Care Products LLC  ANDA040419  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; ACETAMINOPHEN 61919-484-90  Direct_Rx  ANDA040419  HUMAN PRESCRIPTION DRUG  ANDA 
PROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE 50383-804-04  Akorn  ANDA040151  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 63304-562-10  Sun Pharmaceutical Industries, Inc.  ANDA085868  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE 63187-271-04  Proficient Rx LP  ANDA040650  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; ACETAMINOPHEN 72162-2001-5  Bryant Ranch Prepack  ANDA211610  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; ACETAMINOPHEN 49999-060-24  Quality Care Products, LLC  ANDA040419  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; ASPIRIN; BUTALBITAL; CAFFEINE 0722-6094-01  Nexgen Pharma, Inc.  ANDA075231  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 0406-0484-23  SpecGx LLC  ANDA040419  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; ACETAMINOPHEN 45865-219-30  Medsource Pharmaceuticals  ANDA040419  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 12634-526-82  Apotheca, Inc.  ANDA089805  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 67544-474-70  Aphena Pharma Solutions - Tennessee, LLC  ANDA089828  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 67544-474-30  Aphena Pharma Solutions - Tennessee, LLC  ANDA089828  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 12634-526-94  Apotheca, Inc.  ANDA089805  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; ACETAMINOPHEN; BUTALBITAL; CAFFEINE 0722-6670-01  Nexgen Pharma, Inc.  ANDA076560  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; ACETAMINOPHEN 50090-4610-7  A-S Medication Solutions  ANDA040419  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 52959-003-16  H.J. Harkins Company, Inc.  ANDA089805  HUMAN PRESCRIPTION DRUG  ANDA 
BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE; ACETAMINOPHEN 71335-0653-7  Bryant Ranch Prepack  ANDA075929  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 52959-003-10  H.J. Harkins Company, Inc.  ANDA089805  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; ACETAMINOPHEN 76420-103-03  Asclemed USA, Inc.  ANDA040779  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; ACETAMINOPHEN 67544-002-75  Aphena Pharma Solutions - Tennessee, LLC  ANDA040419  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; ACETAMINOPHEN 68071-3100-8  NuCare Pharmaceuticals, Inc.  ANDA202800  HUMAN PRESCRIPTION DRUG  ANDA 
BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE; ACETAMINOPHEN 71335-0653-1  Bryant Ranch Prepack  ANDA075929  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 70518-3575-1  REMEDYREPACK INC.  ANDA040419  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 68071-2681-6  NuCare Pharmaceuticals,Inc.  ANDA211610  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 71335-0336-2  Bryant Ranch Prepack  ANDA202800  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 71335-0336-3  Bryant Ranch Prepack  ANDA202800  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 63187-491-90  Proficient Rx LP  ANDA040779  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
601-630 631-660 661-690 691-720 721-750 751-753

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