Product NDC: | 54868-4431 |
Proprietary Name: | Sonata |
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: | 54868-4431 |
Labeler Name: | Physicians Total Care, Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA020859 |
Marketing Category: | NDA |
Start Marketing Date: | 20040401 |
Package NDC: | 54868-4431-0 |
Package Description: | 30 CAPSULE in 1 BOTTLE (54868-4431-0) |
NDC Code | 54868-4431-0 |
Proprietary Name | Sonata |
Package Description | 30 CAPSULE in 1 BOTTLE (54868-4431-0) |
Product NDC | 54868-4431 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | zaleplon |
Dosage Form Name | CAPSULE |
Route Name | ORAL |
Start Marketing Date | 20040401 |
Marketing Category Name | NDA |
Labeler Name | Physicians Total Care, 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] |