NDC 0781-3003

Flumazenil

Flumazenil

Flumazenil is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Sandoz Inc. The primary component is Flumazenil.

Product ID0781-3003_37418d42-f4fc-4f86-a9d2-4b33b85c4460
NDC0781-3003
Product TypeHuman Prescription Drug
Proprietary NameFlumazenil
Generic NameFlumazenil
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2005-05-03
Marketing CategoryANDA / ANDA
Application NumberANDA077071
Labeler NameSandoz Inc
Substance NameFLUMAZENIL
Active Ingredient Strength0 mg/mL
Pharm ClassesBenzodiazepine Antagonist [EPC]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 0781-3003-95

10 VIAL, MULTI-DOSE in 1 CARTON (0781-3003-95) > 10 mL in 1 VIAL, MULTI-DOSE (0781-3003-70)
Marketing Start Date2005-05-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0781-3003-70 [00781300370]

Flumazenil INJECTION
Marketing CategoryANDA
Application NumberANDA077071
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2005-05-03
Marketing End Date2015-08-31

NDC 0781-3003-95 [00781300395]

Flumazenil INJECTION
Marketing CategoryANDA
Application NumberANDA077071
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2005-05-03
Marketing End Date2015-08-31

NDC 0781-3003-75 [00781300375]

Flumazenil INJECTION
Marketing CategoryANDA
Application NumberANDA077071
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2005-05-03
Marketing End Date2015-08-31

NDC 0781-3003-92 [00781300392]

Flumazenil INJECTION
Marketing CategoryANDA
Application NumberANDA077071
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2005-05-03
Marketing End Date2015-06-30

Drug Details

Active Ingredients

IngredientStrength
FLUMAZENIL.1 mg/mL

OpenFDA Data

SPL SET ID:cf39cdaf-8cb7-4dbb-8672-9cf8e91ac86c
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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