Levalbuterol is a Respiratory (inhalation) Solution in the Human Prescription Drug category. It is labeled and distributed by Teva Pharmaceuticals Usa, Inc.. The primary component is Levalbuterol Hydrochloride.
| Product ID | 0093-4146_43e2d0a6-b135-41c9-b92c-abdc008041ae |
| NDC | 0093-4146 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Levalbuterol |
| Generic Name | Levalbuterol |
| Dosage Form | Solution |
| Route of Administration | RESPIRATORY (INHALATION) |
| Marketing Start Date | 2013-04-29 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA090297 |
| Labeler Name | Teva Pharmaceuticals USA, Inc. |
| Substance Name | LEVALBUTEROL HYDROCHLORIDE |
| Active Ingredient Strength | 1 mg/3mL |
| Pharm Classes | Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
| Marketing Start Date | 2019-01-07 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA090297 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2013-04-29 |
| Marketing Category | ANDA |
| Application Number | ANDA090297 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2013-04-29 |
| Marketing End Date | 2019-12-31 |
| Marketing Category | ANDA |
| Application Number | ANDA090297 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2019-01-07 |
| Marketing Category | ANDA |
| Application Number | ANDA090297 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2019-01-04 |
| Ingredient | Strength |
|---|---|
| LEVALBUTEROL HYDROCHLORIDE | .63 mg/3mL |
| SPL SET ID: | f3ce78d9-e923-400e-b3cd-3e6124ac7f6d |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI | |
| UPC Code |