| NDC Code | 63402-515-30 |
| Package Description | 30 POUCH in 1 CARTON (63402-515-30) > 1 VIAL, SINGLE-DOSE in 1 POUCH (63402-515-00) > .5 mL in 1 VIAL, SINGLE-DOSE |
| Product NDC | 63402-515 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Proprietary Name | Xopenex |
| Non-Proprietary Name | Levalbuterol Hydrochloride |
| Dosage Form | SOLUTION, CONCENTRATE |
| Usage | RESPIRATORY (INHALATION) |
| Start Marketing Date | 20040801 |
| Marketing Category Name | NDA |
| Application Number | NDA020837 |
| Manufacturer | Sunovion Pharmaceuticals Inc. |
| Substance Name | LEVALBUTEROL HYDROCHLORIDE |
| Strength | 1.25 |
| Strength Unit | mg/.5mL |
| Pharmacy Classes | Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] |