NDC 52584-093

Flumazenil

Flumazenil

Flumazenil is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by General Injectables & Vaccines, Inc.. The primary component is Flumazenil.

Product ID52584-093_d0cdc095-f183-4e00-b78c-2196a8600977
NDC52584-093
Product TypeHuman Prescription Drug
Proprietary NameFlumazenil
Generic NameFlumazenil
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2011-02-18
Marketing CategoryANDA / ANDA
Application NumberANDA076256
Labeler NameGeneral Injectables & Vaccines, Inc.
Substance NameFLUMAZENIL
Active Ingredient Strength1 mg/10mL
Pharm ClassesBenzodiazepine Antagonist [EPC]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC SPL Data Element Entries

NDC 52584-093-10 [52584009310]

Flumazenil INJECTION
Marketing CategoryANDA
Application NumberANDA076256
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-02-18
Marketing End Date2017-01-18
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
FLUMAZENIL1 mg/10mL

OpenFDA Data

SPL SET ID:bf7d0367-df73-47d2-b4a0-66bbf5e119a2
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 204508
  • Pharmacological Class

    • Benzodiazepine Antagonist [EPC]

    NDC Crossover Matching brand name "Flumazenil" or generic name "Flumazenil"

    NDCBrand NameGeneric Name
    0143-9683FlumazenilFlumazenil
    0143-9684FlumazenilFlumazenil
    0143-9783Flumazenilflumazenil
    0143-9784Flumazenilflumazenil
    0404-9859Flumazenilflumazenil
    0404-9860Flumazenilflumazenil
    0641-6031FlumazenilFlumazenil
    0641-6032FlumazenilFlumazenil
    0781-3003FlumazenilFlumazenil
    36000-148FlumazenilFlumazenil
    36000-149FlumazenilFlumazenil
    50090-1337Flumazenilflumazenil
    51662-1253FLUMAZENILFLUMAZENIL
    51662-1254FLUMAZENILFLUMAZENIL
    51662-1579FLUMAZENILFLUMAZENIL
    52584-088Flumazenilflumazenil
    52584-089Flumazenilflumazenil
    52584-093FlumazenilFlumazenil
    52584-783FlumazenilFlumazenil
    52584-784FlumazenilFlumazenil
    55154-7474Flumazenilflumazenil
    63323-424FlumazenilFLUMAZENIL
    67457-444FlumazenilFlumazenil
    67457-447FlumazenilFlumazenil
    70385-2002FlumazenilFlumazenil
    70385-2021FlumazenilFlumazenil
    71872-7008FlumazenilFlumazenil
    71872-7038FlumazenilFlumazenil
    71872-7206FlumazenilFlumazenil

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