ZALEPLON - 65862-214-05 - (ZALEPLON)

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Drug Information of ZALEPLON

Product NDC: 65862-214
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: 65862-214
Labeler Name: Aurobindo Pharma Limited
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA078829
Marketing Category: ANDA
Start Marketing Date: 20080606

Package Information of ZALEPLON

Package NDC: 65862-214-05
Package Description: 500 CAPSULE in 1 BOTTLE (65862-214-05)

NDC Information of ZALEPLON

NDC Code 65862-214-05
Proprietary Name ZALEPLON
Package Description 500 CAPSULE in 1 BOTTLE (65862-214-05)
Product NDC 65862-214
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name ZALEPLON
Dosage Form Name CAPSULE
Route Name ORAL
Start Marketing Date 20080606
Marketing Category Name ANDA
Labeler Name Aurobindo Pharma Limited
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