NDC 63629-5437

Hydrocodone Bitartrate and Ibuprofen

Hydrocodone Bitartrate And Ibuprofen

Hydrocodone Bitartrate and Ibuprofen is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is Hydrocodone Bitartrate; Ibuprofen.

Product ID63629-5437_03512d03-fad7-4ab5-81fc-83ca86faef90
NDC63629-5437
Product TypeHuman Prescription Drug
Proprietary NameHydrocodone Bitartrate and Ibuprofen
Generic NameHydrocodone Bitartrate And Ibuprofen
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2010-02-18
Marketing CategoryANDA / ANDA
Application NumberANDA076642
Labeler NameBryant Ranch Prepack
Substance NameHYDROCODONE BITARTRATE; IBUPROFEN
Active Ingredient Strength3 mg/1; mg/1
Pharm ClassesAnti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], Opioid Agonist [EPC], Opioid Agonists [MoA]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 63629-5437-0

15 TABLET in 1 BOTTLE (63629-5437-0)
Marketing Start Date2022-02-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63629-5437-2 [63629543702]

Hydrocodone Bitartrate and Ibuprofen TABLET
Marketing CategoryANDA
Application NumberANDA076642
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-02-18
Inactivation Date2020-01-31

NDC 63629-5437-7 [63629543707]

Hydrocodone Bitartrate and Ibuprofen TABLET
Marketing CategoryANDA
Application NumberANDA076642
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-02-18
Inactivation Date2020-01-31

NDC 63629-5437-8 [63629543708]

Hydrocodone Bitartrate and Ibuprofen TABLET
Marketing CategoryANDA
Application NumberANDA076642
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-02-18
Inactivation Date2020-01-31

NDC 63629-5437-3 [63629543703]

Hydrocodone Bitartrate and Ibuprofen TABLET
Marketing CategoryANDA
Application NumberANDA076642
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-02-18
Inactivation Date2020-01-31

NDC 63629-5437-9 [63629543709]

Hydrocodone Bitartrate and Ibuprofen TABLET
Marketing CategoryANDA
Application NumberANDA076642
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-02-18
Inactivation Date2020-01-31

NDC 63629-5437-1 [63629543701]

Hydrocodone Bitartrate and Ibuprofen TABLET
Marketing CategoryANDA
Application NumberANDA076642
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-02-18
Inactivation Date2020-01-31

NDC 63629-5437-5 [63629543705]

Hydrocodone Bitartrate and Ibuprofen TABLET
Marketing CategoryANDA
Application NumberANDA076642
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-02-18
Inactivation Date2020-01-31

NDC 63629-5437-4 [63629543704]

Hydrocodone Bitartrate and Ibuprofen TABLET
Marketing CategoryANDA
Application NumberANDA076642
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-02-18
Inactivation Date2020-01-31

NDC 63629-5437-6 [63629543706]

Hydrocodone Bitartrate and Ibuprofen TABLET
Marketing CategoryANDA
Application NumberANDA076642
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-02-18
Inactivation Date2020-01-31

NDC 63629-5437-0 [63629543700]

Hydrocodone Bitartrate and Ibuprofen TABLET
Marketing CategoryANDA
Application NumberANDA076642
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-02-18
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
HYDROCODONE BITARTRATE2.5 mg/1

OpenFDA Data

SPL SET ID:03512d03-fad7-4ab5-81fc-83ca86faef90
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 858770
    • 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]

    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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