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] |