| NDC Code | 10370-116-00 |
|---|
| Package Description | 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (10370-116-00) |
|---|
| Product NDC | 10370-116 |
|---|
| Product Type Name | HUMAN PRESCRIPTION DRUG |
|---|
| Proprietary Name | Zolpidem Tartrate |
|---|
| Proprietary Name Suffix | Extended-release |
|---|
| Non-Proprietary Name | Zolpidem Tartrate |
|---|
| Dosage Form | TABLET, FILM COATED, EXTENDED RELEASE |
|---|
| Usage | ORAL |
|---|
| Start Marketing Date | 20111206 |
|---|
| Marketing Category Name | ANDA |
|---|
| Application Number | ANDA078148 |
|---|
| Manufacturer | Par Pharmaceutical, 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 |
|---|