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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 078829

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NDA 078829 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 078829

Tradename:	ZALEPLON
Applicant:	Aurobindo Pharma
Ingredient:	zaleplon
Patents:	0

Pharmacology for NDA: 078829

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

Suppliers and Packaging for NDA: 078829

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ZALEPLON	zaleplon	CAPSULE;ORAL	078829	ANDA	PD-Rx Pharmaceuticals, Inc.	43063-505	43063-505-30	30 CAPSULE in 1 BOTTLE, PLASTIC (43063-505-30)
ZALEPLON	zaleplon	CAPSULE;ORAL	078829	ANDA	Rising Pharma Holdings, Inc.	57237-239	57237-239-01	100 CAPSULE in 1 BOTTLE (57237-239-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	5MG
Approval Date:	Jun 6, 2008	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	10MG
Approval Date:	Jun 6, 2008	TE:	AB	RLD:	No

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