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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; PROMETHAZINE HYDROCHLORIDE 52959-118-08  H.J. Harkins Company,Inc.  ANDA088875  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 33261-001-10  Aidarex Pharmaceuticals LLC  ANDA089805  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; ACETAMINOPHEN 33261-002-60  Aidarex Pharmaceuticals LLC  ANDA089828  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; ACETAMINOPHEN 33261-002-15  Aidarex Pharmaceuticals LLC  ANDA089828  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; ACETAMINOPHEN 63629-3031-1  Bryant Ranch Prepack  ANDA040419  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; ACETAMINOPHEN 67544-882-53  Aphena Pharma Solutions - Tennessee, LLC  ANDA089805  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; ACETAMINOPHEN 67544-882-40  Aphena Pharma Solutions - Tennessee, LLC  ANDA089805  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; ACETAMINOPHEN 67296-1516-6  RedPharm Drug, Inc.  ANDA202800  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 67544-474-80  Aphena Pharma Solutions - Tennessee, LLC  ANDA089828  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 13107-060-05  Aurolife Pharma, LLC  ANDA202800  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 21695-242-60  Rebel Distributors Corp.  ANDA040419  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 71205-001-30  Proficient Rx LP  ANDA088628  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; ACETAMINOPHEN 43353-010-70  Aphena Pharma Solutions - Tennessee, LLC  ANDA040779  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; ACETAMINOPHEN 63629-3031-8  Bryant Ranch Prepack  ANDA040419  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 63187-815-15  Proficient Rx LP  ANDA202800  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 0406-0484-10  SpecGx LLC  ANDA040419  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; ACETAMINOPHEN 67046-903-28  Contract Pharmacy Services-PA  ANDA088628  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; ACETAMINOPHEN 51655-808-53  Northwind Pharmaceuticals  ANDA202800  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; ACETAMINOPHEN 68071-4673-2  NuCare Pharmaceuticals,Inc.  ANDA202800  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE 12634-909-04  Apotheca Inc  ANDA040151  HUMAN PRESCRIPTION DRUG  ANDA 
CHLORPHENIRAMINE MALEATE; CODEINE PHOSPHATE 71269-040-10  Mainpointe Pharmaceuticals  NDA206323  HUMAN PRESCRIPTION DRUG  NDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 76420-103-03  Asclemed USA, Inc.  ANDA040779  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 13107-058-99  Aurolife Pharma, LLC  ANDA202800  HUMAN PRESCRIPTION DRUG  ANDA 
PROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE 72162-2042-2  Bryant Ranch Prepack  ANDA200386  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 50383-339-12  Akorn  ANDA040119  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; BUTALBITAL; ASPIRIN; CAFFEINE 0722-6094-05  Nexgen Pharma, Inc.  ANDA075231  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; ACETAMINOPHEN 0121-1008-12  PAI Holdings, LLC  ANDA087508  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE 66992-840-10  Wraser Llc  ANDA204785  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 50090-1933-2  A-S Medication Solutions  ANDA202800  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; ACETAMINOPHEN 51655-910-54  Northwind Pharmaceuticals, LLC  ANDA211610  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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