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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 204229

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NDA 204229 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 204229

Tradename:	ZOLPIDEM TARTRATE
Applicant:	Ph Health
Ingredient:	zolpidem tartrate
Patents:	0

Pharmacology for NDA: 204229

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

Suppliers and Packaging for NDA: 204229

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ZOLPIDEM TARTRATE	zolpidem tartrate	TABLET;SUBLINGUAL	204229	ANDA	ENDO USA, Inc.	49884-898	49884-898-11	30 POUCH in 1 CARTON (49884-898-11) / 1 TABLET in 1 POUCH (49884-898-52)
ZOLPIDEM TARTRATE	zolpidem tartrate	TABLET;SUBLINGUAL	204229	ANDA	ENDO USA, Inc.	49884-899	49884-899-11	30 POUCH in 1 CARTON (49884-899-11) / 1 TABLET in 1 POUCH (49884-899-52)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;SUBLINGUAL			Strength	1.75MG
Approval Date:	Sep 11, 2017	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;SUBLINGUAL			Strength	3.5MG
Approval Date:	Sep 11, 2017	TE:	AB	RLD:	No

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