NDC Code | 54868-6215-1 |
Package Description | 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (54868-6215-1) |
Product NDC | 54868-6215 |
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 | 20101216 |
Marketing Category Name | NDA |
Application Number | NDA021774 |
Manufacturer | Physicians Total Care, 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 [Chemical/Ingredient],Central Nervous System Depression [PE] |
DEA Schedule | CIV |