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