Budesonide and formoterol fumarate dihydrate NDC 0480-3081

NDC codes

FDA NDC Directory

Product NDC (as listed)0480-3081Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00480-3081Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
0480-3081-31	00480308131	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.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 212212
Marketing start: May 27, 2026
Listing expires: Dec 31, 2027
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

N400480308131 followed by a unit qualifier and the quantity

Package 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 Nov 1, 2022.

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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 212212

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 212212
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