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