Prescription drug · NDA
Symbicort NDC 50090-4508
budesonide and formoterol fumarate dihydrate · 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 |
|---|---|---|---|
| 50090-4508-0 | 50090450800 | 1 POUCH in 1 CARTON (50090-4508-0) / 1 AEROSOL in 1 POUCHMarketed from Sep 4, 2019 |
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)
- Symbicort
- 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 — New Drug ApplicationApplication NDA 021929
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta2-Agonists (Mechanism)Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 50090-4508_6fa58634-230f-4962-9147-d49f17aaabbdSPL ID 6fa58634-230f-4962-9147-d49f17aaabbdSPL set ID 5feb8f35-b237-477a-9836-2a6db2ed6fa7RxCUI 1246304, 1246306UNII 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
N450090450800followed by a unit qualifier and the quantityPackage 50090-4508-00. 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
Current FDA label (SPL), effective .
Indications (excerpt from the label)
SYMBICORT is a combination product containing a corticosteroid and a long-acting beta 2 -adrenergic agonist indicated for: • Treatment of asthma in patients 6 years of age and older. ( 1.1 ) • Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and/or emphysema. ( 1.2 ) Important limitations: • Not indicated for the relief of acute bronchospasm. ( 1.1 , 1.2 ) 1.1 Treatment of Asthma SYMBICORT is indicated for the treatment of asthma in patients 6 years of age and older. SYMBICORT should be used for patients not adequately controlled on a long-term asthma-control medication such as a…
Excerpt only. Read the full label for complete information.
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 |
|---|---|---|---|---|
| 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 |
| Budesonide and Formoterol Fumarate Dihydrate | Budesonide 160 ug/1; Formoterol fumarate 4.5 ug/1 | AerosolRespiratory (Inhalation) | A-S Medication Solutions | 50090-6327 |