Prescription drug · ANDA
Budesonide and formoterol fumarate dihydrate NDC 0480-3081
Budesonide 160 ug/1; Formoterol fumarate 4.5 ug/1 · Aerosol, Metered · Respiratory (Inhalation) · Teva Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0480-3081-31 | 0048030813100480308131 | 1 POUCH in 1 CARTON (0480-3081-31) / 1 CANISTER in 1 POUCH / 120 AEROSOL, METERED in 1 CANISTERMarketed from May 27, 2026 |
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 — 160 ug/1Formoterol fumarate — 4.5 ug/1
- Dosage form
- Aerosol, Metered
- Route
- Respiratory (Inhalation)
- Labeler
- Teva Pharmaceuticals, Inc.NDC labeler code 0480
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212212
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta2-Agonists (Mechanism)Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 0480-3081_3dc30116-6267-434d-bfef-24a1dcb253dbSPL ID 3dc30116-6267-434d-bfef-24a1dcb253dbSPL set ID dd352302-e2fe-4388-b4b0-00b34f6ebe48RxCUI 1246288, 1246304UNII W34SHF8J2K, Q3OKS62Q6XUPC 0304803081311
- 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
N400480308131followed by a unit qualifier and the quantityPackage 00480-3081-31. 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. Budesonide a…
Excerpt only. Read the full label for complete information.
About NDC 0480-3081
- What is NDC 0480-3081?
- 0480-3081 is the product NDC for Budesonide and formoterol fumarate dihydrate, Budesonide 160 ug/1; Formoterol fumarate 4.5 ug/1 aerosol, metered, listed with the FDA by Teva Pharmaceuticals, Inc.. 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?
- Teva Pharmaceuticals, Inc., NDC labeler code 0480. 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 | 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) | A-S Medication Solutions | 50090-6382 | 50090-6382-00 |
| 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 ANDA 212212
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 | Aerosol, MeteredRespiratory (Inhalation) | Teva Pharmaceuticals, Inc. | 0480-3080 |