NDC 61919-118

HYDROCODONE BITARTRATE

Hydrocodone Bitartrate

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

Product ID61919-118_2427de30-b849-4a15-9b59-b5a47af7be04
NDC61919-118
Product TypeHuman Prescription Drug
Proprietary NameHYDROCODONE BITARTRATE
Generic NameHydrocodone Bitartrate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2014-01-01
Marketing CategoryANDA / ANDA
Application NumberANDA040746
Labeler NameDIRECT RX
Substance NameHYDROCODONE BITARTRATE; ACETAMINOPHEN
Active Ingredient Strength10 mg/1; mg/1
Pharm ClassesOpioid Agonist [EPC],Opioid Agonists [MoA]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 61919-118-20

20 TABLET in 1 BOTTLE (61919-118-20)
Marketing Start Date2014-01-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61919-118-60 [61919011860]

HYDROCODONE BITARTRATE TABLET
Marketing CategoryANDA
Application NumberANDA040746
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-01-01

NDC 61919-118-20 [61919011820]

HYDROCODONE BITARTRATE TABLET
Marketing CategoryANDA
Application NumberANDA040746
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-01-01

NDC 61919-118-90 [61919011890]

HYDROCODONE BITARTRATE TABLET
Marketing CategoryANDA
Application NumberANDA040746
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-01-01
Marketing End Date2019-11-25

NDC 61919-118-71 [61919011871]

HYDROCODONE BITARTRATE TABLET
Marketing CategoryANDA
Application NumberANDA040746
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-01-01

NDC 61919-118-30 [61919011830]

HYDROCODONE BITARTRATE TABLET
Marketing CategoryANDA
Application NumberANDA040746
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-01-01
Marketing End Date2019-11-25

NDC 61919-118-26 [61919011826]

HYDROCODONE BITARTRATE TABLET
Marketing CategoryANDA
Application NumberANDA040746
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-01-01

NDC 61919-118-72 [61919011872]

HYDROCODONE BITARTRATE TABLET
Marketing CategoryANDA
Application NumberANDA040746
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-01-01
Marketing End Date2019-11-25

Drug Details

Active Ingredients

IngredientStrength
HYDROCODONE BITARTRATE10 mg/1

OpenFDA Data

SPL SET ID:1ac64001-75dd-4fba-9a89-9969364e5c9a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 856999

    • Pharmacological Class

    • Opioid Agonist [EPC]
    • Opioid Agonists [MoA]

    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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