| Product NDC: | 63402-513 |
| Proprietary Name: | Xopenex |
| Non Proprietary Name: | levalbuterol hydrochloride |
| Active Ingredient(s): | 1.25 mg/3mL & nbsp; levalbuterol hydrochloride |
| Administration Route(s): | RESPIRATORY (INHALATION) |
| Dosage Form(s): | SOLUTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 63402-513 |
| Labeler Name: | Sunovion Pharmaceuticals Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA020837 |
| Marketing Category: | NDA |
| Start Marketing Date: | 19990401 |
| Package NDC: | 63402-513-36 |
| Package Description: | 12 CARTON in 1 BOX (63402-513-36) > 1 POUCH in 1 CARTON (63402-513-05) > 3 VIAL, SINGLE-DOSE in 1 POUCH (63402-513-03) > 3 mL in 1 VIAL, SINGLE-DOSE |
| NDC Code | 63402-513-36 |
| Proprietary Name | Xopenex |
| Package Description | 12 CARTON in 1 BOX (63402-513-36) > 1 POUCH in 1 CARTON (63402-513-05) > 3 VIAL, SINGLE-DOSE in 1 POUCH (63402-513-03) > 3 mL in 1 VIAL, SINGLE-DOSE |
| Product NDC | 63402-513 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | levalbuterol hydrochloride |
| Dosage Form Name | SOLUTION |
| Route Name | RESPIRATORY (INHALATION) |
| Start Marketing Date | 19990401 |
| Marketing Category Name | NDA |
| Labeler Name | Sunovion Pharmaceuticals Inc. |
| Substance Name | LEVALBUTEROL HYDROCHLORIDE |
| Strength Number | 1.25 |
| Strength Unit | mg/3mL |
| Pharmaceutical Classes | Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] |