NDC Code | 68788-7182-6 |
Package Description | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68788-7182-6) |
Product NDC | 68788-7182 |
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 | 20180716 |
Marketing Category Name | NDA AUTHORIZED GENERIC |
Application Number | NDA021774 |
Manufacturer | Preferred Pharmaceuticals Inc. |
Substance Name | ZOLPIDEM TARTRATE |
Strength | 12.5 |
Strength Unit | mg/1 |
Pharmacy Classes | gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [CS],Central Nervous System Depression [PE] |
DEA Schedule | CIV |