Product NDC: | 0378-9681 |
Proprietary Name: | Levalbuterol |
Non Proprietary Name: | levalbuterol |
Active Ingredient(s): | .63 mg/3mL & nbsp; levalbuterol |
Administration Route(s): | RESPIRATORY (INHALATION) |
Dosage Form(s): | SOLUTION |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 0378-9681 |
Labeler Name: | Mylan Pharmaceuticals Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | ANDA077800 |
Marketing Category: | ANDA |
Start Marketing Date: | 20130318 |
Package NDC: | 0378-9681-44 |
Package Description: | 2 POUCH in 1 CARTON (0378-9681-44) > 12 VIAL in 1 POUCH (0378-9681-96) > 3 mL in 1 VIAL |
NDC Code | 0378-9681-44 |
Proprietary Name | Levalbuterol |
Package Description | 2 POUCH in 1 CARTON (0378-9681-44) > 12 VIAL in 1 POUCH (0378-9681-96) > 3 mL in 1 VIAL |
Product NDC | 0378-9681 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | levalbuterol |
Dosage Form Name | SOLUTION |
Route Name | RESPIRATORY (INHALATION) |
Start Marketing Date | 20130318 |
Marketing Category Name | ANDA |
Labeler Name | Mylan Pharmaceuticals Inc. |
Substance Name | LEVALBUTEROL HYDROCHLORIDE |
Strength Number | .63 |
Strength Unit | mg/3mL |
Pharmaceutical Classes | Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] |