Budesonide and Formoterol Fumarate Dihydrate is a Respiratory (inhalation) Aerosol in the Human Prescription Drug category. It is labeled and distributed by Rpk Pharmaceuticals, Inc.. The primary component is Budesonide; Formoterol Fumarate.
| Product ID | 53002-2666_8414c769-98d1-4d0a-9140-b787ccae9b73 |
| NDC | 53002-2666 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Budesonide and Formoterol Fumarate Dihydrate |
| Generic Name | Budesonide And Formoterol Fumarate Dihydrate |
| Dosage Form | Aerosol |
| Route of Administration | RESPIRATORY (INHALATION) |
| Marketing Start Date | 2020-01-03 |
| Marketing Category | NDA AUTHORIZED GENERIC / |
| Application Number | NDA021929 |
| Labeler Name | RPK Pharmaceuticals, Inc. |
| Substance Name | BUDESONIDE; FORMOTEROL FUMARATE |
| Active Ingredient Strength | 80 ug/1; ug/1 |
| Pharm Classes | Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2023-12-31 |
| Marketing Start Date | 2021-01-01 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0310-7370 | Budesonide and Formoterol Fumarate Dihydrate | Budesonide and Formoterol Fumarate Dihydrate |
| 0310-7372 | Budesonide and Formoterol Fumarate Dihydrate | Budesonide and Formoterol Fumarate Dihydrate |
| 53002-2666 | Budesonide and Formoterol Fumarate Dihydrate | Budesonide and Formoterol Fumarate Dihydrate |
| 53002-2667 | Budesonide and Formoterol Fumarate Dihydrate | Budesonide and Formoterol Fumarate Dihydrate |
| 70518-3107 | Budesonide and Formoterol Fumarate Dihydrate | Budesonide and Formoterol Fumarate Dihydrate |
| 0186-0370 | SYMBICORT | Budesonide and Formoterol Fumarate Dihydrate |
| 0186-0372 | SYMBICORT | Budesonide and Formoterol Fumarate Dihydrate |
| 50090-1403 | SYMBICORT | Budesonide and Formoterol Fumarate Dihydrate |
| 70518-2696 | SYMBICORT | Budesonide and Formoterol Fumarate Dihydrate |