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