| NDC Code | 63402-512-36 |
|---|
| Package Description | 12 CARTON in 1 BOX (63402-512-36) > 1 POUCH in 1 CARTON (63402-512-05) > 3 VIAL, SINGLE-DOSE in 1 POUCH (63402-512-03) > 3 mL in 1 VIAL, SINGLE-DOSE |
|---|
| Product NDC | 63402-512 |
|---|
| Product Type Name | HUMAN PRESCRIPTION DRUG |
|---|
| Proprietary Name | Xopenex |
|---|
| Non-Proprietary Name | Levalbuterol Hydrochloride |
|---|
| Dosage Form | SOLUTION |
|---|
| Usage | RESPIRATORY (INHALATION) |
|---|
| Start Marketing Date | 19990401 |
|---|
| Marketing Category Name | NDA |
|---|
| Application Number | NDA020837 |
|---|
| Manufacturer | Sunovion Pharmaceuticals Inc. |
|---|
| Substance Name | LEVALBUTEROL HYDROCHLORIDE |
|---|
| Strength | .63 |
|---|
| Strength Unit | mg/3mL |
|---|
| Pharmacy Classes | Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] |
|---|