Prescription drug · NDA AUTHORIZED GENERIC
Budesonide and Formoterol Fumarate Dihydrate NDC 50090-6382
Budesonide 80 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 |
|---|---|---|---|
| 50090-6382-0 | 5009063820050090638200 | 1 CANISTER in 1 CARTON (50090-6382-0) / 120 AEROSOL in 1 CANISTERMarketed from Feb 27, 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 — 80 ug/1Formoterol fumarate — 4.5 ug/1
- Dosage form
- Aerosol
- Route
- Respiratory (Inhalation)
- Labeler
- A-S Medication SolutionsNDC labeler code 50090
- 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 50090-6382_d969ce47-5da7-4d08-a04f-820c161f2bfcSPL ID d969ce47-5da7-4d08-a04f-820c161f2bfcSPL set ID b974bab9-c6d2-41ad-b930-28f2904c5f9dRxCUI 1246288UNII 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
N450090638200followed by a unit qualifier and the quantityPackage 50090-6382-00. 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)
BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL 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 BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL is indicated for the treatment of asthma in patients 6 years of age and older. BUDESO…
Excerpt only. Read the full label for complete information.
About NDC 50090-6382
- What is NDC 50090-6382?
- 50090-6382 is the product NDC for Budesonide and Formoterol Fumarate Dihydrate, Budesonide 80 ug/1; Formoterol fumarate 4.5 ug/1 aerosol, listed with the FDA by A-S Medication Solutions. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Budesonide and Formoterol Fumarate Dihydrate.
- What is the active ingredient?
- Budesonide, Formoterol fumarate.
- Who is the labeler?
- A-S Medication Solutions, NDC labeler code 50090. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Budesonide and Formoterol Fumarate Dihydrate?
- 7 other product NDCs are listed under this name. See all Budesonide and Formoterol Fumarate Dihydrate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Budesonide and Formoterol Fumarate Dihydrate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Budesonide and formoterol fumarate dihydrate | Budesonide 80 ug/1; Formoterol fumarate 4.5 ug/1 | Aerosol, MeteredRespiratory (Inhalation) | Teva Pharmaceuticals, Inc. | 0480-3080 | 00480-3080-31 |
| Budesonide and formoterol fumarate dihydrate | Budesonide 160 ug/1; Formoterol fumarate 4.5 ug/1 | Aerosol, MeteredRespiratory (Inhalation) | Teva Pharmaceuticals, Inc. | 0480-3081 | 00480-3081-31 |
| Budesonide and Formoterol Fumarate Dihydrate | Budesonide 160 ug/1; Formoterol fumarate 4.5 ug/1 | AerosolRespiratory (Inhalation) | AstraZeneca Pharmaceuticals LP | 0310-7370 | 00310-7370-20 |
| Budesonide and Formoterol Fumarate Dihydrate | Budesonide 80 ug/1; Formoterol fumarate 4.5 ug/1 | AerosolRespiratory (Inhalation) | AstraZeneca Pharmaceuticals LP | 0310-7372 | 00310-7372-20 |
| Budesonide and Formoterol Fumarate Dihydrate | Budesonide 160 ug/1; Formoterol fumarate 4.5 ug/1 | AerosolRespiratory (Inhalation) | A-S Medication Solutions | 50090-6327 | 50090-6327-00 |
| Budesonide and Formoterol Fumarate Dihydrate | Budesonide 80 ug/1; Formoterol fumarate 4.5 ug/1 | AerosolRespiratory (Inhalation) | Sportpharm LLC | 85766-113 | 85766-0113-12 |
| Budesonide and Formoterol Fumarate Dihydrate | Budesonide 160 ug/1; Formoterol fumarate 4.5 ug/1 | AerosolRespiratory (Inhalation) | Sportpharm LLC | 85766-114 | 85766-0114-12 |
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 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 |
| Budesonide and Formoterol Fumarate Dihydrate | Budesonide 160 ug/1; Formoterol fumarate 4.5 ug/1 | AerosolRespiratory (Inhalation) | A-S Medication Solutions | 50090-6327 |
| 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 80 ug/1; Formoterol fumarate 4.5 ug/1 | AerosolRespiratory (Inhalation) | AstraZeneca Pharmaceuticals LP | 0186-0372 |
| 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 160 ug/1; Formoterol fumarate 4.5 ug/1 | AerosolRespiratory (Inhalation) | A-S Medication Solutions | 50090-4508 |
| 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 |
| Symbicortbudesonide and formoterol fumarate dihydrate | Budesonide 80 ug/1; Formoterol fumarate 4.5 ug/1 | AerosolRespiratory (Inhalation) | Sportpharm LLC | 85766-184 |