NDC Code | 68788-8376-6 |
Package Description | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68788-8376-6) |
Product NDC | 68788-8376 |
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 | 20230301 |
Marketing Category Name | ANDA |
Application Number | ANDA204170 |
Manufacturer | Preferred Pharmaceuticals Inc. |
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 |