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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 68071-3061-2  NuCare Pharmaceuticals, Inc.  ANDA202800  HUMAN PRESCRIPTION DRUG  ANDA 
CAFFEINE; CODEINE PHOSPHATE; ASPIRIN; BUTALBITAL 69238-1993-1  Amneal Pharmaceuticals NY LLC  ANDA074951  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; ACETAMINOPHEN 61502-903-10  EPM Packaging Inc  ANDA088627  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 63187-106-15  Proficient Rx LP  ANDA040419  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 71205-001-20  Proficient Rx LP  ANDA088628  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 71610-111-54  Aphena Pharma Solutions - Tennessee, LLC  ANDA040419  HUMAN PRESCRIPTION DRUG  ANDA 
ASPIRIN; BUTALBITAL; CODEINE PHOSPHATE; CAFFEINE 51991-074-01  Breckenridge Pharmaceutical, Inc.  ANDA075231  HUMAN PRESCRIPTION DRUG  ANDA 
PROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE 17856-0605-1  ATLANTIC BIOLOGICALS CORP.  ANDA088875  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 61919-023-90  DIRECT RX  ANDA040779  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; ACETAMINOPHEN 50383-339-12  Akorn  ANDA040119  HUMAN PRESCRIPTION DRUG  ANDA 
BUTALBITAL; ACETAMINOPHEN; CODEINE PHOSPHATE; CAFFEINE 63629-3152-4  Bryant Ranch Prepack  NDA020232  HUMAN PRESCRIPTION DRUG  NDA AUTHORIZED GENERIC 
CODEINE PHOSPHATE; ACETAMINOPHEN 63187-815-20  Proficient Rx LP  ANDA202800  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE ANHYDROUS 10191-1034-2  Remedy Makers    HUMAN PRESCRIPTION DRUG  unapproved homeopathic 
ACETAMINOPHEN; CODEINE PHOSPHATE 63187-106-60  Proficient Rx LP  ANDA040419  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 52959-446-30  H.J. Harkins Company, Inc.  ANDA202800  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; ACETAMINOPHEN 63629-1188-1  Bryant Ranch Prepack  ANDA211610  HUMAN PRESCRIPTION DRUG  ANDA 
PROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE 70166-555-05  Lohxa  ANDA088875  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; ACETAMINOPHEN; CAFFEINE; BUTALBITAL 51991-073-01  Breckenridge Pharmaceutical, Inc.  ANDA076560  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; ACETAMINOPHEN 49999-026-30  Quality Care Products LLC  ANDA040419  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 50436-3227-7  Unit Dose Services  ANDA040779  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 68071-4673-3  NuCare Pharmaceuticals,Inc.  ANDA202800  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; ACETAMINOPHEN 13107-060-30  Aurolife Pharma, LLC  ANDA202800  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 53489-160-01  Mutual Pharmaceutical Company, Inc.  ANDA089672  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 67046-903-30  Contract Pharmacy Services-PA  ANDA088628  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 50090-4610-2  A-S Medication Solutions  ANDA040419  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; ACETAMINOPHEN 67544-882-53  Aphena Pharma Solutions - Tennessee, LLC  ANDA089805  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 12634-526-85  Apotheca, Inc.  ANDA089805  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; ACETAMINOPHEN 67296-0065-4  RedPharm Drug  ANDA040419  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CAFFEINE; BUTALBITAL; CODEINE PHOSPHATE 0054-3000-01  Hikma Pharmaceuticals USA Inc.  ANDA215138  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 58118-4484-8  Clinical Solutions Wholesale, LLC  ANDA040419  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
601-630 631-660 661-690 691-720 721-750 751-760

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