SYMBICORT
- Product NDC
- 50090-4510
- 11-digit product format
- 500904510
- Labeler code
- 50090
- Product ID
- 50090-4510_c59eb034-bb30-494f-aad1-85b734a19df2
- 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
- Marketing start
- 2007-05-29
- 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 |
|---|
| 50090-4510-0 | 50090451000 | 1 POUCH in 1 CARTON (50090-4510-0) / 1 AEROSOL in 1 POUCH | 1 pouch | 2019-09-04 | No | No | Historical |