Prescription drug · NDA AUTHORIZED GENERIC
Budesonide and Formoterol Fumarate Dihydrate NDC 0310-7372
Budesonide 80 ug/1; Formoterol fumarate 4.5 ug/1 · Aerosol · Respiratory (Inhalation) · AstraZeneca Pharmaceuticals LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0310-7372-20 | 00310737220 | 1 POUCH in 1 CARTON (0310-7372-20) / 1 CANISTER in 1 POUCH / 120 AEROSOL in 1 CANISTERMarketed from Jan 3, 2020 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- 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 0310-7372_b500fba8-8294-4c20-b51e-2ce674acf1b3SPL ID b500fba8-8294-4c20-b51e-2ce674acf1b3SPL set ID 1d266fe8-52e3-4f85-a037-c5c1afa15e60RxCUI 1246288, 1246304UNII W34SHF8J2K, Q3OKS62Q6X
- 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
N400310737220followed by a unit qualifier and the quantityPackage 00310-7372-20. 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.
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 |
| 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 |