| NDC Code | 61919-449-30 |
|---|
| Package Description | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (61919-449-30) |
|---|
| Product NDC | 61919-449 |
|---|
| 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 | 20180315 |
|---|
| Marketing Category Name | ANDA |
|---|
| Application Number | ANDA078179 |
|---|
| Manufacturer | DIRECT RX |
|---|
| 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 |
|---|