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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 090374

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NDA 090374 describes ZALEPLON, which is a drug marketed by Aurobindo Pharma, Chartwell Molecular, Hikma, Hikma Pharms, Natco Pharma, Orbion Pharms, Teva Pharms, Unichem, and Upsher Smith Labs, and is included in ten NDAs. It is available from nine suppliers. Additional details are available on the ZALEPLON profile page.

The generic ingredient in ZALEPLON is zaleplon. There are twelve drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the zaleplon profile page.

Summary for 090374

Tradename:	ZALEPLON
Applicant:	Orbion Pharms
Ingredient:	zaleplon
Patents:	0

Pharmacology for NDA: 090374

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

Suppliers and Packaging for NDA: 090374

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ZALEPLON	zaleplon	CAPSULE;ORAL	090374	ANDA	Preferred Pharmaceuticals Inc.	68788-8725	68788-8725-1	100 CAPSULE in 1 BOTTLE (68788-8725-1)
ZALEPLON	zaleplon	CAPSULE;ORAL	090374	ANDA	Preferred Pharmaceuticals Inc.	68788-8725	68788-8725-2	20 CAPSULE in 1 BOTTLE (68788-8725-2)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	5MG
Approval Date:	Sep 17, 2009	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	10MG
Approval Date:	Sep 17, 2009	TE:	AB	RLD:	No

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