Levalbuterol Inhalation Solution is a Respiratory (inhalation) Solution in the Human Prescription Drug category. It is labeled and distributed by Sun Pharmaceutical Industries, Inc.. The primary component is Levalbuterol Hydrochloride.
| Product ID | 47335-746_927ff610-9e74-442d-9144-21d5e06cf0a0 |
| NDC | 47335-746 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Levalbuterol Inhalation Solution |
| Generic Name | Levalbuterol Inhalation Solution |
| Dosage Form | Solution |
| Route of Administration | RESPIRATORY (INHALATION) |
| Marketing Start Date | 2018-12-01 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA207820 |
| Labeler Name | Sun Pharmaceutical Industries, 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 | 2020-07-01 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA207820 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2018-12-01 |
| Marketing Category | ANDA |
| Application Number | ANDA207820 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2018-12-01 |
| Marketing Category | ANDA |
| Application Number | ANDA207820 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2018-12-01 |
| Marketing End Date | 2020-04-30 |
| Marketing Category | ANDA |
| Application Number | ANDA207820 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2018-12-01 |
| Marketing End Date | 2020-04-30 |
| Ingredient | Strength |
|---|---|
| LEVALBUTEROL HYDROCHLORIDE | .63 mg/3mL |
| SPL SET ID: | 85a59e0c-ff09-49a6-b7b8-616e033107b4 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 16714-094 | Levalbuterol Inhalation Solution | Levalbuterol Inhalation Solution |
| 16714-095 | Levalbuterol Inhalation Solution | Levalbuterol Inhalation Solution |
| 16714-096 | Levalbuterol Inhalation Solution | Levalbuterol Inhalation Solution |
| 47335-743 | Levalbuterol Inhalation Solution | Levalbuterol Inhalation Solution |
| 47335-746 | Levalbuterol Inhalation Solution | Levalbuterol Inhalation Solution |
| 47335-753 | Levalbuterol Inhalation Solution | Levalbuterol Inhalation Solution |