NDC Code | 43353-727-60 |
Package Description | 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43353-727-60) |
Product NDC | 43353-727 |
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 | Aphena Pharma Solutions - Tennessee, LLC |
Substance Name | ZOLPIDEM TARTRATE |
Strength | 12.5 |
Strength Unit | mg/1 |
Pharmacy Classes | Central Nervous System Depression [PE], GABA A Receptor Positive Modulators [MoA], gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC] |
DEA Schedule | CIV |