NDC 0378-1631
FORMOTEROL FUMARATE
Formoterol Fumarate Dihydrate
FORMOTEROL FUMARATE is a Respiratory (inhalation) Solution in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Formoterol Fumarate.
| Product ID | 0378-1631_273877a4-ac76-4640-b05c-d56b0d70484d |
| NDC | 0378-1631 |
| Product Type | Human Prescription Drug |
| Proprietary Name | FORMOTEROL FUMARATE |
| Generic Name | Formoterol Fumarate Dihydrate |
| Dosage Form | Solution |
| Route of Administration | RESPIRATORY (INHALATION) |
| Marketing Start Date | 2021-06-22 |
| Marketing Category | NDA AUTHORIZED GENERIC / |
| Application Number | NDA022007 |
| Labeler Name | Mylan Pharmaceuticals Inc. |
| Substance Name | FORMOTEROL FUMARATE |
| Active Ingredient Strength | 20 ug/2mL |
| Pharm Classes | Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2023-12-31 |