| Product NDC: | 65862-215 |
| 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: | 65862-215 |
| Labeler Name: | Aurobindo Pharma Limited |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA078829 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20080606 |
| Package NDC: | 65862-215-01 |
| Package Description: | 100 CAPSULE in 1 BOTTLE (65862-215-01) |
| NDC Code | 65862-215-01 |
| Proprietary Name | ZALEPLON |
| Package Description | 100 CAPSULE in 1 BOTTLE (65862-215-01) |
| Product NDC | 65862-215 |
| 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 | 10 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | gamma-Aminobutyric Acid A Receptor Agonist [EPC],GABA A Agonists [MoA],Central Nervous System Depression [PE] |