| Product NDC: | 0378-6993 |
| Proprietary Name: | Levalbuterol Hydrochloride |
| Non Proprietary Name: | levalbuterol hydrochloride |
| Active Ingredient(s): | 1.25 mg/.5mL & nbsp; levalbuterol hydrochloride |
| Administration Route(s): | RESPIRATORY (INHALATION) |
| Dosage Form(s): | SOLUTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 0378-6993 |
| Labeler Name: | Mylan Pharmaceuticals Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA078309 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20090828 |
| Package NDC: | 0378-6993-93 |
| Package Description: | 30 POUCH in 1 CARTON (0378-6993-93) > 1 VIAL in 1 POUCH (0378-6993-31) > .5 mL in 1 VIAL |
| NDC Code | 0378-6993-93 |
| Proprietary Name | Levalbuterol Hydrochloride |
| Package Description | 30 POUCH in 1 CARTON (0378-6993-93) > 1 VIAL in 1 POUCH (0378-6993-31) > .5 mL in 1 VIAL |
| Product NDC | 0378-6993 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | levalbuterol hydrochloride |
| Dosage Form Name | SOLUTION |
| Route Name | RESPIRATORY (INHALATION) |
| Start Marketing Date | 20090828 |
| Marketing Category Name | ANDA |
| Labeler Name | Mylan Pharmaceuticals Inc. |
| Substance Name | LEVALBUTEROL HYDROCHLORIDE |
| Strength Number | 1.25 |
| Strength Unit | mg/.5mL |
| Pharmaceutical Classes | Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] |