Prescription drug · NDA AUTHORIZED GENERIC
Budesonide and Formoterol Fumarate Dihydrate NDC 50090-6327
Budesonide 160 ug/1; Formoterol fumarate 4.5 ug/1 · Aerosol · Respiratory (Inhalation) · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-6327-0 | 50090632700 | 1 POUCH in 1 CARTON (50090-6327-0) / 1 AEROSOL in 1 POUCHMarketed from Jan 12, 2023 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Budesonide and Formoterol Fumarate Dihydrate
- Generic name (nonproprietary)
- budesonide and formoterol fumarate dihydrate
- Active ingredients
- Budesonide — 160 ug/1Formoterol fumarate — 4.5 ug/1
- Dosage form
- Aerosol
- Route
- Respiratory (Inhalation)
- Labeler
- A-S Medication Solutions
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 021929
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta2-Agonists (Mechanism)Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 50090-6327_dd1cf8de-0389-4e98-be80-dc164a6dbcffSPL ID dd1cf8de-0389-4e98-be80-dc164a6dbcffSPL set ID 0ce4cd21-ac96-4b39-9e1c-49f86c87fa1aRxCUI 1246304UNII Q3OKS62Q6X, W34SHF8J2K
- Pharmacologic class
- Corticosteroid; beta2-Adrenergic Agonist
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N450090632700followed by a unit qualifier and the quantityPackage 50090-6327-00. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Label details couldn’t be retrieved right now. Open the label on DailyMed.
Other NDCs under NDA 021929
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Symbicortbudesonide and formoterol fumarate dihydrate | Budesonide 160 ug/1; Formoterol fumarate 4.5 ug/1 | AerosolRespiratory (Inhalation) | A-S Medication Solutions | 50090-4508 |
| Budesonide and Formoterol Fumarate Dihydrate | Budesonide 80 ug/1; Formoterol fumarate 4.5 ug/1 | AerosolRespiratory (Inhalation) | A-S Medication Solutions | 50090-6382 |
| Symbicortbudesonide and formoterol fumarate dihydrate | Budesonide 160 ug/1; Formoterol fumarate 4.5 ug/1 | AerosolRespiratory (Inhalation) | A-S Medication Solutions | 50090-4509 |
| Symbicortbudesonide and formoterol fumarate dihydrate | Budesonide 80 ug/1; Formoterol fumarate 4.5 ug/1 | AerosolRespiratory (Inhalation) | A-S Medication Solutions | 50090-4510 |
| Budesonide and Formoterol Fumarate Dihydrate | Budesonide 80 ug/1; Formoterol fumarate 4.5 ug/1 | AerosolRespiratory (Inhalation) | Sportpharm LLC | 85766-113 |
| Budesonide and Formoterol Fumarate Dihydrate | Budesonide 160 ug/1; Formoterol fumarate 4.5 ug/1 | AerosolRespiratory (Inhalation) | Sportpharm LLC | 85766-114 |
| Symbicortbudesonide and formoterol fumarate dihydrate | Budesonide 160 ug/1; Formoterol fumarate 4.5 ug/1 | AerosolRespiratory (Inhalation) | AstraZeneca Pharmaceuticals LP | 0186-0370 |
| Symbicortbudesonide and formoterol fumarate dihydrate | Budesonide 160 ug/1; Formoterol fumarate 4.5 ug/1 | AerosolRespiratory (Inhalation) | A-S Medication Solutions | 50090-1403 |
| Symbicortbudesonide and formoterol fumarate dihydrate | Budesonide 80 ug/1; Formoterol fumarate 4.5 ug/1 | AerosolRespiratory (Inhalation) | AstraZeneca Pharmaceuticals LP | 0186-0372 |
| Budesonide and Formoterol Fumarate Dihydrate | Budesonide 160 ug/1; Formoterol fumarate 4.5 ug/1 | AerosolRespiratory (Inhalation) | AstraZeneca Pharmaceuticals LP | 0310-7370 |
| Budesonide and Formoterol Fumarate Dihydrate | Budesonide 80 ug/1; Formoterol fumarate 4.5 ug/1 | AerosolRespiratory (Inhalation) | AstraZeneca Pharmaceuticals LP | 0310-7372 |
| Symbicortbudesonide and formoterol fumarate dihydrate | Budesonide 80 ug/1; Formoterol fumarate 4.5 ug/1 | AerosolRespiratory (Inhalation) | Sportpharm LLC | 85766-184 |