NDC 52584-089

Flumazenil

Flumazenil

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

Product ID52584-089_1f125ec1-ad8e-4403-8f92-5524d5d3e132
NDC52584-089
Product TypeHuman Prescription Drug
Proprietary NameFlumazenil
Generic NameFlumazenil
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2019-05-24
Marketing CategoryANDA / ANDA
Application NumberANDA076755
Labeler NameGeneral Injectables and Vaccines, Inc.
Substance NameFLUMAZENIL
Active Ingredient Strength0 mg/mL
Pharm ClassesBenzodiazepine Antagonist [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 52584-089-01

1 VIAL, MULTI-DOSE in 1 BAG (52584-089-01) > 10 mL in 1 VIAL, MULTI-DOSE
Marketing Start Date2019-05-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52584-089-01 [52584008901]

Flumazenil INJECTION
Marketing CategoryANDA
Application NumberANDA076755
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-05-24

Drug Details

Active Ingredients

IngredientStrength
FLUMAZENIL.1 mg/mL

OpenFDA Data

SPL SET ID:70b1aaf5-b53b-4c42-80b7-d260c4364845
Manufacturer
UNII

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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