NDC 61919-494

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 ID61919-494_2690b62f-9629-6bab-e054-00144ff8d46c
NDC61919-494
Product TypeHuman Prescription Drug
Proprietary NameHYDROCODONE BITARTRATE
Generic NameHydrocodone Bitartrate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2014-01-01
Marketing CategoryANDA / ANDA
Application NumberANDA040736
Labeler NameDIRECT RX
Substance NameHYDROCODONE BITARTRATE; ACETAMINOPHEN
Active Ingredient Strength5 mg/1; mg/1
Pharm ClassesOpioid Agonist [EPC],Opioid Agonists [MoA]
DEA ScheduleCII
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 61919-494-60

60 TABLET in 1 BOTTLE (61919-494-60)
Marketing Start Date2014-01-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61919-494-30 [61919049430]

HYDROCODONE BITARTRATE TABLET
Marketing CategoryANDA
Application NumberANDA040736
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-01-01

NDC 61919-494-72 [61919049472]

HYDROCODONE BITARTRATE TABLET
Marketing CategoryANDA
Application NumberANDA040736
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-10-27
Inactivation Date2020-01-31

NDC 61919-494-20 [61919049420]

HYDROCODONE BITARTRATE TABLET
Marketing CategoryANDA
Application NumberANDA040736
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-07-23

NDC 61919-494-90 [61919049490]

HYDROCODONE BITARTRATE TABLET
Marketing CategoryANDA
Application NumberANDA040736
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-01-01

NDC 61919-494-60 [61919049460]

HYDROCODONE BITARTRATE TABLET
Marketing CategoryANDA
Application NumberANDA040736
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-01-01

Drug Details

Active Ingredients

IngredientStrength
HYDROCODONE BITARTRATE5 mg/1

OpenFDA Data

SPL SET ID:fa2a09a8-7835-4261-a9b1-b35adab27de7
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 857002

    • 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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