Budesonide and Formoterol Fumarate Dihydrate
- Product NDC
- 50090-6382
- 11-digit product format
- 500906382
- Labeler code
- 50090
- Product ID
- 50090-6382_d969ce47-5da7-4d08-a04f-820c161f2bfc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Budesonide and Formoterol Fumarate Dihydrate
- Dosage form
- AEROSOL
- Route
- RESPIRATORY (INHALATION)
- Labeler
- A-S Medication Solutions
- Application
- NDA021929
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2020-01-03
- Substance
- BUDESONIDE; FORMOTEROL FUMARATE
- Active strength
- 80; 4.5 ug/1; ug/1
- Pharmacologic classes
- Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| Q3OKS62Q6X | BUDESONIDE | 51333-22-3 | BUDESONIDE |
| W34SHF8J2K | FORMOTEROL FUMARATE | 183814-30-4 | FORMOTEROL FUMARATE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 50090-6382-0 | 50090638200 | 1 CANISTER in 1 CARTON (50090-6382-0) / 120 AEROSOL in 1 CANISTER | 1 canister | 2023-02-27 | No | No | Historical |