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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 076955

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NDA 076955 describes FLUMAZENIL, which is a drug marketed by Baxter Hlthcare Corp, Dr Reddys, Fresenius Kabi Usa, Hikma, Hikma Farmaceutica, Rising, Sagent Pharms, and Sandoz, and is included in nine NDAs. It is available from eleven suppliers. Additional details are available on the FLUMAZENIL profile page.

The generic ingredient in FLUMAZENIL is flumazenil. There are four drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the flumazenil profile page.

Summary for 076955

Tradename:	FLUMAZENIL
Applicant:	Fresenius Kabi Usa
Ingredient:	flumazenil
Patents:	0

Pharmacology for NDA: 076955

Medical Subject Heading (MeSH) Categories for 076955

Antidotes
GABA Modulators

Suppliers and Packaging for NDA: 076955

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FLUMAZENIL	flumazenil	INJECTABLE;INJECTION	076955	ANDA	HF Acquisition Co LLC, DBA HealthFirst	51662-1579	51662-1579-1	5 mL in 1 VIAL, MULTI-DOSE (51662-1579-1)
FLUMAZENIL	flumazenil	INJECTABLE;INJECTION	076955	ANDA	Fresenius Kabi USA, LLC	63323-424	63323-424-05	10 VIAL, MULTI-DOSE in 1 TRAY (63323-424-05) / 5 mL in 1 VIAL, MULTI-DOSE (63323-424-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	1MG/10ML (0.1MG/ML)
Approval Date:	Oct 12, 2004	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	0.5MG/5ML (0.1MG/ML)
Approval Date:	Oct 12, 2004	TE:	AP	RLD:	No

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