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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 076379

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NDA 076379 describes MIDAZOLAM HYDROCHLORIDE, which is a drug marketed by Apothecon, Baxter Hlthcare Corp, Bedford, Ben Venue, Epic Pharma Llc, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hospira, Hospira Inc, Igi Labs Inc, Intl Medicated, Intl Medication, Micro Labs, Ph Health, Rising, Padagis Us, Pai Holdings, Pharm Assoc, Sun Pharm Inds Ltd, Rafa Labs Ltd, and Onesource Specialty, and is included in thirty-six NDAs. It is available from nineteen suppliers. Additional details are available on the MIDAZOLAM HYDROCHLORIDE profile page.

The generic ingredient in MIDAZOLAM HYDROCHLORIDE is midazolam hydrochloride. There are nine drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the midazolam hydrochloride profile page.

Summary for 076379

Tradename:	MIDAZOLAM HYDROCHLORIDE
Applicant:	Padagis Us
Ingredient:	midazolam hydrochloride
Patents:	0

Pharmacology for NDA: 076379

Medical Subject Heading (MeSH) Categories for 076379

Adjuvants, Anesthesia
Anesthetics, Intravenous
Anti-Anxiety Agents
GABA Modulators
Hypnotics and Sedatives

Suppliers and Packaging for NDA: 076379

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MIDAZOLAM HYDROCHLORIDE	midazolam hydrochloride	SYRUP;ORAL	076379	ANDA	Padagis US LLC	0574-0150	0574-0150-04	1 BOTTLE, GLASS in 1 CARTON (0574-0150-04) / 118 mL in 1 BOTTLE, GLASS
MIDAZOLAM HYDROCHLORIDE	midazolam hydrochloride	SYRUP;ORAL	076379	ANDA	Bryant Ranch Prepack	72162-1109	72162-1109-2	1 BOTTLE, GLASS in 1 CARTON (72162-1109-2) / 118 mL in 1 BOTTLE, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SYRUP;ORAL			Strength	EQ 2MG BASE/ML
Approval Date:	May 2, 2005	TE:	AA	RLD:	No

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