ZALEPLON - 52959-957-60 - (ZALEPLON)

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Drug Information of ZALEPLON

Product NDC: 52959-957
Proprietary Name: ZALEPLON
Non Proprietary Name: ZALEPLON
Active Ingredient(s): 10    mg/1 & nbsp;   ZALEPLON
Administration Route(s): ORAL
Dosage Form(s): CAPSULE
Coding System: National Drug Codes(NDC)

Labeler Information of ZALEPLON

Product NDC: 52959-957
Labeler Name: H.J. Harkins Company, Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA078989
Marketing Category: ANDA
Start Marketing Date: 20101215

Package Information of ZALEPLON

Package NDC: 52959-957-60
Package Description: 60 CAPSULE in 1 BOTTLE (52959-957-60)

NDC Information of ZALEPLON

NDC Code 52959-957-60
Proprietary Name ZALEPLON
Package Description 60 CAPSULE in 1 BOTTLE (52959-957-60)
Product NDC 52959-957
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name ZALEPLON
Dosage Form Name CAPSULE
Route Name ORAL
Start Marketing Date 20101215
Marketing Category Name ANDA
Labeler Name H.J. Harkins Company, Inc.
Substance Name ZALEPLON
Strength Number 10
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