NDC 49999-588

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 Lake Erie Medical Dba Quality Care Products Llc. The primary component is Hydrocodone Bitartrate; Ibuprofen.

Product ID49999-588_9309c8e8-2168-4fc1-a12f-01fb41fb4d67
NDC49999-588
Product TypeHuman Prescription Drug
Proprietary NameHydrocodone Bitartrate and Ibuprofen
Generic NameHydrocodone Bitartrate And Ibuprofen
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2010-11-17
Marketing CategoryANDA / ANDA
Application NumberANDA076604
Labeler NameLake Erie Medical DBA Quality Care Products LLC
Substance NameHYDROCODONE BITARTRATE; IBUPROFEN
Active Ingredient Strength8 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]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 49999-588-30

30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (49999-588-30)
Marketing Start Date2010-11-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 49999-588-01 [49999058801]

Hydrocodone Bitartrate and Ibuprofen TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076604
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-11-17
Marketing End Date2014-06-01

NDC 49999-588-60 [49999058860]

Hydrocodone Bitartrate and Ibuprofen TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076604
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-11-17
Marketing End Date2018-12-31

NDC 49999-588-30 [49999058830]

Hydrocodone Bitartrate and Ibuprofen TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076604
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-11-17
Marketing End Date2017-12-31

NDC 49999-588-90 [49999058890]

Hydrocodone Bitartrate and Ibuprofen TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076604
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-11-17
Marketing End Date2014-06-01

NDC 49999-588-15 [49999058815]

Hydrocodone Bitartrate and Ibuprofen TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076604
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-11-17
Marketing End Date2014-06-01

Drug Details

Active Ingredients

IngredientStrength
HYDROCODONE BITARTRATE7.5 mg/1

OpenFDA Data

SPL SET ID:d4aa609c-1e1d-4970-958a-ba4b13611d00
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]

    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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