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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
ACETAMINOPHEN; CODEINE PHOSPHATE 67544-882-90  Aphena Pharma Solutions - Tennessee, LLC  ANDA089805  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; CHLORPHENIRAMINE MALEATE 0722-7184-01  Nexgen Pharma, Inc.  NDA206323  HUMAN PRESCRIPTION DRUG  NDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 53002-3410-1  RPK Pharmaceuticals, Inc.  ANDA087508  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 0121-1008-00  Pharmaceutical Associates, Inc.  ANDA087508  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 61919-273-90  DirectRX  ANDA088629  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 63629-1494-6  Bryant Ranch Prepack  ANDA088628  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 64850-642-12  Elite Laboratories, Inc.  ANDA212418  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 50383-340-15  Hi-Tech Pharmacal Co., Inc.  ANDA040119  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 33261-001-30  Aidarex Pharmaceuticals LLC  ANDA089805  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 63629-1494-7  Bryant Ranch Prepack  ANDA088628  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE ANHYDROUS 10191-1035-2  Remedy Makers    HUMAN PRESCRIPTION DRUG  unapproved homeopathic 
ACETAMINOPHEN; CODEINE PHOSPHATE 50090-3011-7  A-S Medication Solutions  ANDA040419  HUMAN PRESCRIPTION DRUG  ANDA 
CAFFEINE; CODEINE PHOSPHATE; BUTALBITAL; ASPIRIN 54868-1037-4  PHYSICIANS TOTAL CARE, INC  ANDA074359  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 55154-7553-0  Cardinal Health  ANDA040419  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE ANHYDROUS; CHLORPHENIRAMINE MALEATE 69654-480-01  Aytu BioPharma, Inc.  NDA207768  HUMAN PRESCRIPTION DRUG  NDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 67544-003-90  Aphena Pharma Solutions - Tennessee, LLC  ANDA040419  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 50090-1934-0  A-S Medication Solutions  ANDA202800  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 50090-4610-0  A-S Medication Solutions  ANDA040419  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 66336-059-12  Dispensing Solutions, Inc.  ANDA089805  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CAFFEINE; CODEINE PHOSPHATE; BUTALBITAL 63629-3152-6  Bryant Ranch Prepack  NDA020232  HUMAN PRESCRIPTION DRUG  NDA AUTHORIZED GENERIC 
CODEINE ANHYDROUS 10191-1034-2  Remedy Makers    HUMAN PRESCRIPTION DRUG  unapproved homeopathic 
ACETAMINOPHEN; CODEINE PHOSPHATE 53489-159-10  Mutual Pharmaceutical Company, Inc.  ANDA089671  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 50090-4610-2  A-S Medication Solutions  ANDA040419  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CAFFEINE; CODEINE PHOSPHATE; BUTALBITAL 79739-7028-1  LGM Pharma Solutions, LLC  ANDA076560  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 61502-903-15  EPM Packaging Inc  ANDA088627  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 71335-0701-1  Bryant Ranch Prepack  ANDA088629  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 0121-0504-00  Pharmaceutical Associates, Inc.  ANDA087508  HUMAN PRESCRIPTION DRUG  ANDA 
CAFFEINE; CODEINE PHOSPHATE; BUTALBITAL; ASPIRIN 0722-6094-01  Nexgen Pharma, Inc.  ANDA075231  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 45865-439-30  Medsource Pharmaceuticals  ANDA202800  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 61919-053-60  DIRECT RX  ANDA202800  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
601-630 631-660 661-690 691-720 721-750 751-780 781-810 811-840 841-867

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