Last Updated: July 27, 2026

Details for New Drug Application (NDA): 220717

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NDA 220717 describes ZOLPIDEM TARTRATE, which is a drug marketed by Almatica, Umedica Labs Pvt, Actavis Elizabeth, Actavis Labs Fl Inc, Apotex, Breckenridge, Lupin, 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-seven NDAs. It is available from forty-one 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-four suppliers are listed for this compound. Additional details are available on the zolpidem tartrate profile page.

Summary for 220717

Tradename:	ZOLPIDEM TARTRATE
Applicant:	Umedica Labs Pvt
Ingredient:	zolpidem tartrate
Patents:	0

Pharmacology for NDA: 220717

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

Suppliers and Packaging for NDA: 220717

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ZOLPIDEM TARTRATE	zolpidem tartrate	CAPSULE;ORAL	220717	ANDA	TORRENT PHARMACEUTICALS LIMITED	13668-775	13668-775-30	30 CAPSULE in 1 BOTTLE (13668-775-30)
ZOLPIDEM TARTRATE	zolpidem tartrate	CAPSULE;ORAL	220717	ANDA	Umedica Laboratories USA Inc.	60290-089	60290-089-01	30 CAPSULE in 1 BOTTLE (60290-089-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	7.5MG
Approval Date:	May 12, 2026	TE:	AB	RLD:	No

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