Zaleplon - 0054-0085-25 - (Zaleplon)

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Drug Information of Zaleplon

Product NDC: 0054-0085
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: 0054-0085
Labeler Name: Roxane Laboratories, Inc
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA077237
Marketing Category: ANDA
Start Marketing Date: 20080606

Package Information of Zaleplon

Package NDC: 0054-0085-25
Package Description: 100 CAPSULE in 1 BOTTLE (0054-0085-25)

NDC Information of Zaleplon

NDC Code 0054-0085-25
Proprietary Name Zaleplon
Package Description 100 CAPSULE in 1 BOTTLE (0054-0085-25)
Product NDC 0054-0085
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 Roxane Laboratories, 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