| NDC Code | 0591-2281-10 |
|---|
| Package Description | 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0591-2281-10) |
|---|
| Product NDC | 0591-2281 |
|---|
| 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 | 20130325 |
|---|
| Marketing Category Name | ANDA |
|---|
| Application Number | ANDA090153 |
|---|
| Manufacturer | Actavis Pharma, Inc. |
|---|
| Substance Name | ZOLPIDEM TARTRATE |
|---|
| Strength | 6.25 |
|---|
| 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 |
|---|