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Last Updated: March 27, 2026

Details for New Drug Application (NDA): 078970

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NDA 078970 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, Apotex Inc, Aurobindo Pharma, Chartwell Molecular, Hikma, Invagen Pharms, Mylan Pharms Inc, Rising, Senores Pharms, 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-three 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-six suppliers are listed for this compound. Additional details are available on the zolpidem tartrate profile page.

Summary for 078970

Tradename:	ZOLPIDEM TARTRATE
Applicant:	Lupin Ltd
Ingredient:	zolpidem tartrate
Patents:	0

Pharmacology for NDA: 078970

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

Suppliers and Packaging for NDA: 078970

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ZOLPIDEM TARTRATE	zolpidem tartrate	TABLET, EXTENDED RELEASE;ORAL	078970	ANDA	A-S Medication Solutions	50090-7557	50090-7557-2	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-7557-2)
ZOLPIDEM TARTRATE	zolpidem tartrate	TABLET, EXTENDED RELEASE;ORAL	078970	ANDA	ST. MARY'S MEDICAL PARK PHARMACY	60760-819	60760-819-30	30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (60760-819-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	6.25MG
Approval Date:	Sep 11, 2013	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	12.5MG
Approval Date:	Sep 11, 2013	TE:	AB	RLD:	No

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