| NDC Code | 68788-8376-9 |
|---|
| Package Description | 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68788-8376-9) |
|---|
| 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 Agonists [MoA], Pyridines [CS], gamma-Aminobutyric Acid-ergic Agonist [EPC] |
|---|
| DEA Schedule | CIV |
|---|