Levalbuterol is a Respiratory (inhalation) Solution in the Human Prescription Drug category. It is labeled and distributed by Burel Pharmaceuticals, Inc.. The primary component is Levalbuterol Hydrochloride.
| Product ID | 35573-444_055db544-4c08-4142-ba8e-88fbe0364c54 |
| NDC | 35573-444 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Levalbuterol |
| Generic Name | Levalbuterol Hydrochloride |
| Dosage Form | Solution |
| Route of Administration | RESPIRATORY (INHALATION) |
| Marketing Start Date | 2021-04-01 |
| Marketing Category | ANDA / |
| Application Number | ANDA203653 |
| Labeler Name | Burel Pharmaceuticals, 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 | 2022-12-31 |
| Marketing Start Date | 2021-04-01 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0093-4145 | Levalbuterol | Levalbuterol |
| 0093-4146 | Levalbuterol | Levalbuterol |
| 0093-4147 | Levalbuterol | Levalbuterol |
| 0093-4148 | Levalbuterol | Levalbuterol |
| 0115-9930 | Levalbuterol | Levalbuterol Hydrochloride |
| 0115-9931 | Levalbuterol | Levalbuterol Hydrochloride |
| 0115-9932 | Levalbuterol | Levalbuterol Hydrochloride |
| 0378-6993 | Levalbuterol | levalbuterol |
| 0378-9680 | Levalbuterol | levalbuterol |
| 0378-9681 | Levalbuterol | levalbuterol |
| 0378-9682 | Levalbuterol | levalbuterol |
| 0378-9690 | Levalbuterol | Levalbuterol |
| 0378-9691 | Levalbuterol | Levalbuterol |
| 0378-9692 | Levalbuterol | Levalbuterol |
| 68788-6777 | Levalbuterol | Levalbuterol |
| 76204-900 | Levalbuterol | Levalbuterol |
| 76204-800 | Levalbuterol | Levalbuterol |
| 76204-700 | Levalbuterol | Levalbuterol |
| 63187-953 | Levalbuterol | Levalbuterol |
| 65862-944 | Levalbuterol | Levalbuterol |
| 65862-942 | LEVALBUTEROL | LEVALBUTEROL |
| 65862-945 | Levalbuterol | Levalbuterol |
| 65862-943 | Levalbuterol | Levalbuterol |
| 68071-5027 | Levalbuterol | Levalbuterol |
| 68071-2340 | Levalbuterol | Levalbuterol |
| 17478-171 | Xopenex | Levalbuterol Hydrochloride |
| 17478-172 | Xopenex | Levalbuterol Hydrochloride |
| 17478-173 | Xopenex | Levalbuterol Hydrochloride |
| 17478-174 | Xopenex | Levalbuterol Hydrochloride |
| 21695-153 | Xopenex | levalbuterol hydrochloride |