NDC 61919-296

HYDROCODONE BITARTRATE

Hydrocodone Bitartrate

HYDROCODONE BITARTRATE is a Oral Tablet, Coated in the Human Prescription Drug category. It is labeled and distributed by Direct Rx. The primary component is Hydrocodone Bitartrate; Ibuprofen.

Product ID61919-296_3fdeac85-5fd8-04fa-e054-00144ff88e88
NDC61919-296
Product TypeHuman Prescription Drug
Proprietary NameHYDROCODONE BITARTRATE
Generic NameHydrocodone Bitartrate
Dosage FormTablet, Coated
Route of AdministrationORAL
Marketing Start Date2014-01-01
Marketing CategoryANDA / ANDA
Application NumberANDA077723
Labeler NameDIRECT RX
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 FlagE
Listing Certified Through2017-12-31

Packaging

NDC 61919-296-30

30 TABLET, COATED in 1 BOTTLE (61919-296-30)
Marketing Start Date2015-01-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61919-296-30 [61919029630]

HYDROCODONE BITARTRATE TABLET, COATED
Marketing CategoryANDA
Application NumberANDA077723
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-01-01

Drug Details

Active Ingredients

IngredientStrength
HYDROCODONE BITARTRATE7.5 mg/1

OpenFDA Data

SPL SET ID:c386c4c5-f2f1-4078-a6fb-f120f56912e4
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" or generic name "Hydrocodone Bitartrate"

    NDCBrand NameGeneric Name
    47781-392Hydrocodone BitartrateHydrocodone Bitartrate
    47781-393Hydrocodone BitartrateHydrocodone Bitartrate
    47781-394Hydrocodone BitartrateHydrocodone Bitartrate
    47781-395Hydrocodone BitartrateHydrocodone Bitartrate
    47781-396Hydrocodone BitartrateHydrocodone Bitartrate
    47781-397Hydrocodone BitartrateHydrocodone Bitartrate
    47781-398Hydrocodone BitartrateHydrocodone Bitartrate
    47781-409Hydrocodone BitartrateHydrocodone Bitartrate
    47781-410Hydrocodone BitartrateHydrocodone Bitartrate
    47781-411Hydrocodone BitartrateHydrocodone Bitartrate
    47781-412Hydrocodone BitartrateHydrocodone Bitartrate
    47781-413Hydrocodone BitartrateHydrocodone Bitartrate
    47781-414Hydrocodone BitartrateHydrocodone Bitartrate
    61919-494HYDROCODONE BITARTRATEHYDROCODONE BITARTRATE
    61919-118HYDROCODONE BITARTRATEHYDROCODONE BITARTRATE
    61919-296HYDROCODONE BITARTRATEHYDROCODONE BITARTRATE
    65224-950Hydrocodone BitartrateHydrocodone Bitartrate
    65224-920Hydrocodone BitartrateHydrocodone Bitartrate
    65224-930Hydrocodone BitartrateHydrocodone Bitartrate
    65224-915Hydrocodone BitartrateHydrocodone Bitartrate
    65224-940Hydrocodone BitartrateHydrocodone Bitartrate
    65224-910Hydrocodone BitartrateHydrocodone Bitartrate
    43376-210Zohydrohydrocodone bitartrate
    43376-215Zohydrohydrocodone bitartrate
    43376-220Zohydrohydrocodone bitartrate
    43376-230Zohydrohydrocodone bitartrate
    43376-240Zohydrohydrocodone bitartrate
    43376-250Zohydrohydrocodone bitartrate
    43376-310Zohydrohydrocodone bitartrate
    43376-315Zohydrohydrocodone bitartrate
    43376-320Zohydrohydrocodone bitartrate
    43376-330Zohydrohydrocodone bitartrate
    43376-340Zohydrohydrocodone bitartrate
    43376-350Zohydrohydrocodone bitartrate
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