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Last Updated: December 17, 2025

Details for New Drug Application (NDA): 077388

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NDA 077388 describes ZOLPIDEM TARTRATE, which is a drug marketed by Almatica, Actavis Elizabeth, Actavis Labs Fl Inc, Apotex, Breckenridge, Lupin Ltd, Ph Health, Sandoz, Sun Pharm, Synthon Pharms, Acme Labs, Anda Repository, Apotex Inc, Aurobindo Pharma, Chartwell Molecular, Hikma, Invagen Pharms, Mylan Pharms Inc, Rising, Strides Pharma, Strides Pharma Intl, Sun Pharm Inds Inc, Sun Pharm Inds Ltd, Sun Pharm Industries, Teva, Torrent Pharms, Watson Labs, Wockhardt, Yung Shin Pharm, Dr Reddys, Novel Labs Inc, and Pharmobedient, and is included in thirty-six NDAs. It is available from forty-four suppliers. Additional details are available on the ZOLPIDEM TARTRATE profile page.

The generic ingredient in ZOLPIDEM TARTRATE is zolpidem tartrate. There are thirty-three drug master file entries for this compound. Forty-seven suppliers are listed for this compound. Additional details are available on the zolpidem tartrate profile page.

Summary for 077388

Tradename:	ZOLPIDEM TARTRATE
Applicant:	Chartwell Molecular
Ingredient:	zolpidem tartrate
Patents:	0

Pharmacology for NDA: 077388

Mechanism of Action	GABA A Receptor Positive Modulators
Physiological Effect	Central Nervous System Depression

Suppliers and Packaging for NDA: 077388

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ZOLPIDEM TARTRATE	zolpidem tartrate	TABLET;ORAL	077388	ANDA	Chartwell RX, LLC	62135-778	62135-778-90	90 TABLET in 1 BOTTLE (62135-778-90)
ZOLPIDEM TARTRATE	zolpidem tartrate	TABLET;ORAL	077388	ANDA	Chartwell RX, LLC	62135-779	62135-779-90	90 TABLET in 1 BOTTLE (62135-779-90)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Jul 30, 2012	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Jul 30, 2012	TE:	AB	RLD:	No

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