| Product NDC: | 63402-510 |
| Proprietary Name: | Xopenex HFA |
| Non Proprietary Name: | levalbuterol tartrate |
| Active Ingredient(s): | 45 ug/1 & nbsp; levalbuterol tartrate |
| Administration Route(s): | ORAL |
| Dosage Form(s): | AEROSOL, METERED |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 63402-510 |
| Labeler Name: | Sunovion Pharmaceuticals Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA021730 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20051201 |
| Package NDC: | 63402-510-04 |
| Package Description: | 1 INHALER in 1 CARTON (63402-510-04) > 80 AEROSOL, METERED in 1 INHALER |
| NDC Code | 63402-510-04 |
| Proprietary Name | Xopenex HFA |
| Package Description | 1 INHALER in 1 CARTON (63402-510-04) > 80 AEROSOL, METERED in 1 INHALER |
| Product NDC | 63402-510 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | levalbuterol tartrate |
| Dosage Form Name | AEROSOL, METERED |
| Route Name | ORAL |
| Start Marketing Date | 20051201 |
| Marketing Category Name | NDA |
| Labeler Name | Sunovion Pharmaceuticals Inc. |
| Substance Name | LEVALBUTEROL TARTRATE |
| Strength Number | 45 |
| Strength Unit | ug/1 |
| Pharmaceutical Classes | Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] |