zaleplon - 29300-131-05 - (zaleplon)

Alphabetical Index


Drug Information of zaleplon

Product NDC: 29300-131
Proprietary Name: zaleplon
Non Proprietary Name: zaleplon
Active Ingredient(s): 5    mg/1 & nbsp;   zaleplon
Administration Route(s): ORAL
Dosage Form(s): CAPSULE
Coding System: National Drug Codes(NDC)

Labeler Information of zaleplon

Product NDC: 29300-131
Labeler Name: Unichem Pharmaceuticals (USA), Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA078989
Marketing Category: ANDA
Start Marketing Date: 20090505

Package Information of zaleplon

Package NDC: 29300-131-05
Package Description: 500 CAPSULE in 1 BOTTLE, PLASTIC (29300-131-05)

NDC Information of zaleplon

NDC Code 29300-131-05
Proprietary Name zaleplon
Package Description 500 CAPSULE in 1 BOTTLE, PLASTIC (29300-131-05)
Product NDC 29300-131
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name zaleplon
Dosage Form Name CAPSULE
Route Name ORAL
Start Marketing Date 20090505
Marketing Category Name ANDA
Labeler Name Unichem Pharmaceuticals (USA), Inc.
Substance Name ZALEPLON
Strength Number 5
Strength Unit mg/1
Pharmaceutical Classes gamma-Aminobutyric Acid A Receptor Agonist [EPC],GABA A Agonists [MoA],Central Nervous System Depression [PE]

Complete Information of zaleplon


General Information