| Product NDC: | 76204-003 |
| Proprietary Name: | Levalbuterol Hydrochloride |
| 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: | 76204-003 |
| Labeler Name: | Ritedose Pharmaceuticals, LLC |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA020837 |
| Marketing Category: | NDA AUTHORIZED GENERIC |
| Start Marketing Date: | 20121201 |
| Package NDC: | 76204-003-24 |
| Package Description: | 2 POUCH in 1 CARTON (76204-003-24) > 12 AMPULE in 1 POUCH > 3 mL in 1 AMPULE |
| NDC Code | 76204-003-24 |
| Proprietary Name | Levalbuterol Hydrochloride |
| Package Description | 2 POUCH in 1 CARTON (76204-003-24) > 12 AMPULE in 1 POUCH > 3 mL in 1 AMPULE |
| Product NDC | 76204-003 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Levalbuterol Hydrochloride |
| Dosage Form Name | SOLUTION |
| Route Name | RESPIRATORY (INHALATION) |
| Start Marketing Date | 20121201 |
| Marketing Category Name | NDA AUTHORIZED GENERIC |
| Labeler Name | Ritedose Pharmaceuticals, LLC |
| Substance Name | LEVALBUTEROL HYDROCHLORIDE |
| Strength Number | 1.25 |
| Strength Unit | mg/3mL |
| Pharmaceutical Classes | Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] |