NDC 33261-378

HYDROCODONE BITARTRATE AND IBUPROFEN

Hydrocodone Bitartrate And Ibuprofen

HYDROCODONE BITARTRATE AND IBUPROFEN is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Aidarex Pharmaceuticals Llc. The primary component is Hydrocodone Bitartrate; Ibuprofen.

Product ID33261-378_8e28c38a-8d9f-489f-82f9-d13d7d7a4c97
NDC33261-378
Product TypeHuman Prescription Drug
Proprietary NameHYDROCODONE BITARTRATE AND IBUPROFEN
Generic NameHydrocodone Bitartrate And Ibuprofen
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2008-08-27
Marketing CategoryANDA / ANDA
Application NumberANDA076604
Labeler NameAidarex Pharmaceuticals LLC
Substance NameHYDROCODONE BITARTRATE; IBUPROFEN
Active Ingredient Strength8 mg/1; mg/1
Pharm ClassesOpioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 33261-378-00

100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (33261-378-00)
Marketing Start Date2008-08-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 33261-378-90 [33261037890]

HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076604
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-08-27
Inactivation Date2020-01-31

NDC 33261-378-02 [33261037802]

HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076604
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-08-27
Inactivation Date2020-01-31

NDC 33261-378-60 [33261037860]

HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076604
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-08-27
Inactivation Date2020-01-31

NDC 33261-378-00 [33261037800]

HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076604
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-08-27
Inactivation Date2020-01-31

NDC 33261-378-10 [33261037810]

HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076604
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-08-27
Inactivation Date2020-01-31

NDC 33261-378-30 [33261037830]

HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076604
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-08-27
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
HYDROCODONE BITARTRATE7.5 mg/1

OpenFDA Data

SPL SET ID:80140ebb-0d9c-4cab-bb8b-951849291b13
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 858798
    • PHarm Class EPC
  • Nonsteroidal Anti-inflammatory Drug [EPC]
    • NUI Code
  • N0000000160
  • N0000175722
  • N0000175721

    • Pharmacological Class

    • Opioid Agonist [EPC]
    • Opioid Agonists [MoA]
    • Cyclooxygenase Inhibitors [MoA]
    • Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient]
    • Nonsteroidal Anti-inflammatory Drug [EPC]
    • Anti-Inflammatory Agents
    • Non-Steroidal [CS]

    NDC Crossover Matching brand name "HYDROCODONE BITARTRATE AND IBUPROFEN" or generic name "Hydrocodone Bitartrate And Ibuprofen"

    NDCBrand NameGeneric Name
    0603-3584Hydrocodone Bitartrate and Ibuprofenhydrocodone bitartrate and ibuprofen
    0603-3586Hydrocodone Bitartrate and Ibuprofenhydrocodone bitartrate and ibuprofen
    0603-3897Hydrocodone Bitartrate and Ibuprofenhydrocodone bitartrate and ibuprofen
    13107-004Hydrocodone Bitartrate and IbuprofenHydrocodone Bitartrate and Ibuprofen
    33261-378HYDROCODONE BITARTRATE AND IBUPROFENHYDROCODONE BITARTRATE AND IBUPROFEN
    49999-588Hydrocodone Bitartrate and IbuprofenHydrocodone Bitartrate and Ibuprofen
    53746-116Hydrocodone Bitartrate and IbuprofenHydrocodone Bitartrate and Ibuprofen
    53746-117Hydrocodone Bitartrate and IbuprofenHydrocodone Bitartrate and Ibuprofen
    53746-145Hydrocodone Bitartrate and IbuprofenHydrocodone Bitartrate and Ibuprofen
    53746-146Hydrocodone Bitartrate and IbuprofenHydrocodone Bitartrate and Ibuprofen
    68084-841Hydrocodone Bitartrate and IbuprofenHydrocodone Bitartrate and Ibuprofen
    71335-0094HYDROCODONE BITARTRATE AND IBUPROFENHYDROCODONE BITARTRATE AND IBUPROFEN
    71335-0104Hydrocodone Bitartrate and IbuprofenHydrocodone Bitartrate and Ibuprofen
    55700-639Hydrocodone Bitartrate and IbuprofenHydrocodone Bitartrate and Ibuprofen
    57664-203Hydrocodone bitartrate and ibuprofenHydrocodone bitartrate and ibuprofen
    57664-280Hydrocodone bitartrate and ibuprofenHydrocodone bitartrate and ibuprofen
    57664-281Hydrocodone bitartrate and ibuprofenHydrocodone bitartrate and ibuprofen
    57664-102Hydrocodone bitartrate and ibuprofenHydrocodone bitartrate and ibuprofen
    62037-524HYDROCODONE BITARTRATE AND IBUPROFENHYDROCODONE BITARTRATE AND IBUPROFEN
    63629-5437Hydrocodone Bitartrate and IbuprofenHydrocodone Bitartrate and Ibuprofen
    63739-557Hydrocodone Bitartrate and IbuprofenHydrocodone Bitartrate and Ibuprofen
    67296-1282HYDROCODONE BITARTRATE AND IBUPROFENHYDROCODONE BITARTRATE AND IBUPROFEN
    67296-1655Hydrocodone Bitartrate and IbuprofenHydrocodone Bitartrate and Ibuprofen
    50991-579IBUDONEhydrocodone bitartrate and ibuprofen
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