NDC 0143-9783

Flumazenil

Flumazenil

Flumazenil is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by West-ward Pharmaceuticals Corp. The primary component is Flumazenil.

Product ID0143-9783_c895c79c-cb7b-43da-ab94-85bad5187479
NDC0143-9783
Product TypeHuman Prescription Drug
Proprietary NameFlumazenil
Generic NameFlumazenil
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2007-01-01
Marketing CategoryANDA / ANDA
Application NumberANDA078527
Labeler NameWest-Ward Pharmaceuticals Corp
Substance NameFLUMAZENIL
Active Ingredient Strength0 mg/mL
Pharm ClassesBenzodiazepine Antagonist [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0143-9783-10

10 VIAL, MULTI-DOSE in 1 BOX (0143-9783-10) > 10 mL in 1 VIAL, MULTI-DOSE (0143-9783-01)
Marketing Start Date2007-01-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0143-9783-02 [00143978302]

Flumazenil INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA078527
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-01-01
Marketing End Date2016-04-22

NDC 0143-9783-10 [00143978310]

Flumazenil INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA078527
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2007-01-01

NDC 0143-9783-01 [00143978301]

Flumazenil INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA078527
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2016-04-22

Drug Details

Active Ingredients

IngredientStrength
FLUMAZENIL.1 mg/mL

OpenFDA Data

SPL SET ID:442ed32b-b508-40cc-9915-ff05674566da
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 204508

    • Pharmacological Class

    • Benzodiazepine Antagonist [EPC]
    • 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
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.