NDC 50991-579

IBUDONE

Hydrocodone Bitartrate And Ibuprofen

IBUDONE is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Poly Pharmaceuticals. The primary component is Hydrocodone Bitartrate; Ibuprofen.

Product ID50991-579_7fafdef6-38b6-823a-e053-2991aa0a7fb4
NDC50991-579
Product TypeHuman Prescription Drug
Proprietary NameIBUDONE
Generic NameHydrocodone Bitartrate And Ibuprofen
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2006-11-06
Marketing End Date2019-09-30
Marketing CategoryANDA / ANDA
Application NumberANDA077723
Labeler NamePoly Pharmaceuticals
Substance NameHYDROCODONE BITARTRATE; IBUPROFEN
Active Ingredient Strength10 mg/1; mg/1
Pharm ClassesOpioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
DEA ScheduleCII
NDC Exclude FlagN

Packaging

NDC 50991-579-01

100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50991-579-01)
Marketing Start Date2006-11-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50991-579-40 [50991057940]

IBUDONE TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077723
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-03-03
Marketing End Date2015-10-21

NDC 50991-579-01 [50991057901]

IBUDONE TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077723
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2006-11-06
Marketing End Date2019-03-31

Drug Details

Active Ingredients

IngredientStrength
HYDROCODONE BITARTRATE10 mg/1

OpenFDA Data

SPL SET ID:73bcc732-5215-475a-9d59-4c11abf8bf17
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 859317
  • 858780
  • 858778
  • 859315
    • PHarm Class EPC
  • Nonsteroidal Anti-inflammatory Drug [EPC]
    • UPC Code
  • 0350991579017
  • 0350991578010
    • 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]

    Medicade Reported Pricing

    50991057901 IBUDONE 10-200 MG TABLET

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "IBUDONE" or generic name "Hydrocodone Bitartrate And Ibuprofen"

    NDCBrand NameGeneric Name
    50991-579IBUDONEhydrocodone bitartrate and ibuprofen
    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

    Trademark Results [IBUDONE]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    IBUDONE
    IBUDONE
    77379188 3551524 Live/Registered
    Vintage Pharmaceuticals, LLC
    2008-01-24
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