NDC Code | 0955-1703-10 |
Package Description | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0955-1703-10) |
Product NDC | 0955-1703 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Proprietary Name | Zolpidem Tartrate |
Non-Proprietary Name | Zolpidem Tartrate |
Dosage Form | TABLET, FILM COATED, EXTENDED RELEASE |
Usage | ORAL |
Start Marketing Date | 20101206 |
Marketing Category Name | NDA AUTHORIZED GENERIC |
Application Number | NDA021774 |
Manufacturer | Winthrop U.S, a business of sanofi-aventis U.S. LLC |
Substance Name | ZOLPIDEM TARTRATE |
Strength | 12.5 |
Strength Unit | mg/1 |
Pharmacy Classes | Central Nervous System Depression [PE], GABA A Agonists [MoA], Pyridines [CS], gamma-Aminobutyric Acid-ergic Agonist [EPC] |
DEA Schedule | CIV |