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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 21695-243-60  Rebel Distributors Corp.  ANDA040419  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 50436-3227-2  Unit Dose Services  ANDA040779  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE 70408-185-31  Nostrum Laboratories, Inc.  ANDA090180  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 67544-882-15  Aphena Pharma Solutions - Tennessee, LLC  ANDA089805  HUMAN PRESCRIPTION DRUG  ANDA 
PROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE 12634-907-28  Apotheca Inc.  ANDA090180  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 71335-0256-8  Bryant Ranch Prepack  ANDA202800  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 67544-882-53  Aphena Pharma Solutions - Tennessee, LLC  ANDA089805  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE SULFATE 0527-1698-01  Lannett Company, Inc.  ANDA203046  HUMAN PRESCRIPTION DRUG  ANDA 
CHLORPHENIRAMINE MALEATE; CODEINE PHOSPHATE 71269-040-30  Mainpointe Pharmaceuticals  NDA206323  HUMAN PRESCRIPTION DRUG  NDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 67544-474-60  Aphena Pharma Solutions - Tennessee, LLC  ANDA089828  HUMAN PRESCRIPTION DRUG  ANDA 
PHENYLEPHRINE HYDROCHLORIDE; CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE 0121-0925-16  PAI Holdings, LLC  ANDA040660  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 50090-4610-1  A-S Medication Solutions  ANDA040419  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; ACETAMINOPHEN 49999-060-90  Quality Care Products, LLC  ANDA040419  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 67046-901-30  Coupler Enterprises Inc.  ANDA040419  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE 72162-2042-2  Bryant Ranch Prepack  ANDA200386  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 45865-466-30  Medsource Pharmaceuticals  ANDA202800  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; ACETAMINOPHEN 63187-815-60  Proficient Rx LP  ANDA202800  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 50090-3011-5  A-S Medication Solutions  ANDA040419  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 71335-0701-1  Bryant Ranch Prepack  ANDA088629  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE 0722-6670-05  Nexgen Pharma, Inc.  ANDA076560  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 12634-526-50  Apotheca, Inc.  ANDA089805  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE 12634-909-16  Apotheca Inc  ANDA040151  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 68387-250-60  Keltman Pharmaceuticals, Inc.  ANDA089805  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 70518-4104-0  REMEDYREPACK INC.  ANDA089805  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 10544-032-15  Blenheim Pharmacal, Inc.  ANDA040419  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; ACETAMINOPHEN 67544-002-90  Aphena Pharma Solutions - Tennessee, LLC  ANDA040419  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; ACETAMINOPHEN 70518-2764-1  REMEDYREPACK INC.  ANDA211610  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 33261-001-28  Aidarex Pharmaceuticals LLC  ANDA089805  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; ACETAMINOPHEN 76420-103-10  Asclemed USA, Inc.  ANDA040779  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; BUTALBITAL; CODEINE PHOSPHATE; CAFFEINE 79739-7028-5  LGM Pharma Solutions, LLC  ANDA076560  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
601-630 631-660 661-690 691-720 721-735

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