AMBIEN - ZOLPIDEM TARTRATE
Navigation: NDC > Supplier starting with: S > STAT RX USA LLC| Field | Value |
|---|---|
| NDC Code: | 16590-436 |
| Proprietary Name: | AMBIEN |
| Suffix: | CR |
| Non-Proprietary Name: | ZOLPIDEM TARTRATE |
| Dosage Form: | TABLET, COATED |
| Method: | ORAL |
| Original Marketing Date: | 30-06-2009 |
| Category Name: | NDA |
| Application Number: | NDA021774 |
| Labeler: | STAT RX USA LLC |
| Substance Name: | ZOLPIDEM TARTRATE |
| Active Numerator Strength: | 12.5 |
| Active Ingredient Unit: | mg/1 |
| Pharm Classes: | gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] |
| DEA Schedule: | CIV |