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] |