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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 078413

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NDA 078413 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 078413

Tradename:	ZOLPIDEM TARTRATE
Applicant:	Aurobindo Pharma
Ingredient:	zolpidem tartrate
Patents:	0

Pharmacology for NDA: 078413

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

Suppliers and Packaging for NDA: 078413

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ZOLPIDEM TARTRATE	zolpidem tartrate	TABLET;ORAL	078413	ANDA	NorthStar Rx LLC	16714-621	16714-621-01	100 TABLET, FILM COATED in 1 BOTTLE (16714-621-01)
ZOLPIDEM TARTRATE	zolpidem tartrate	TABLET;ORAL	078413	ANDA	NorthStar Rx LLC	16714-621	16714-621-02	500 TABLET, FILM COATED in 1 BOTTLE (16714-621-02)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	May 4, 2007	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	May 4, 2007	TE:	AB	RLD:	No

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