Budesonide and Formoterol Fumarate Dihydrate is a Respiratory (inhalation) Aerosol in the Human Prescription Drug category. It is labeled and distributed by Remedyrepack Inc.. The primary component is Budesonide; Formoterol Fumarate.
| Product ID | 70518-3107_c3549bda-7564-63ba-e053-2995a90afcc0 |
| NDC | 70518-3107 |
| 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 | 2021-05-27 |
| Marketing Category | NDA AUTHORIZED GENERIC / |
| Application Number | NDA021929 |
| Labeler Name | REMEDYREPACK INC. |
| Substance Name | BUDESONIDE; FORMOTEROL FUMARATE |
| Active Ingredient Strength | 160 ug/1; ug/1 |
| Pharm Classes | Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2022-12-31 |
| Marketing Start Date | 2021-05-27 |
| 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 |