Budesonide Inhalation (budesonide) NDC 0115-1687

NDC codes

FDA NDC Directory

Product NDC (as listed)0115-1687Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00115-1687Add 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
0115-1687-74	00115168774	6 POUCH in 1 CARTON (0115-1687-74) / 5 VIAL in 1 POUCH (0115-1687-76) / 2 mL in 1 VIALMarketed from Aug 4, 2016

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 Inhalation
Generic name (nonproprietary): budesonide
Active ingredients: Budesonide — .25 mg/2mL
Dosage form: Suspension
Route: Respiratory (Inhalation)
Labeler: Amneal Pharmaceuticals of New York LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078404
Marketing start: Aug 4, 2016
Listing expires: Dec 31, 2027
Other FDA classes: Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers: Product ID 0115-1687_dbb6c949-66b1-4f60-ab96-442dd8b4ea19SPL ID dbb6c949-66b1-4f60-ab96-442dd8b4ea19SPL set ID e8ef9489-83a2-4817-b21c-ea3fecd8c8ddRxCUI 349094, 351109UNII Q3OKS62Q6XUPC 0301151687745
Pharmacologic class: Corticosteroid

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

N400115168774 followed by a unit qualifier and the quantity

Package 00115-1687-74. 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 Feb 2, 2026.

Indications (excerpt from the label)

Budesonide inhalation suspension is an inhaled corticosteroid indicated for: Maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age. ( 1.1 ) Limitations of Use: Not indicated for the relief of acute bronchospasm. ( 1.1 ) 1.1 Maintenance Treatment of Asthma Budesonide inhalation suspension is indicated for the maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age. Limitations of Use: Budesonide inhalation suspension is NOT indicated for the relief of acute bronchospasm.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 078404

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

FDA NDC Directory listings under ANDA 078404
Product	Strength	Form · route	Labeler	Product NDC
Budesonide Inhalationbudesonide	Budesonide .5 mg/2mL	SuspensionRespiratory (Inhalation)	Amneal Pharmaceuticals of New York LLC	0115-1689
Budesonide Inhalationbudesonide	Budesonide .25 mg/2mL	SuspensionRespiratory (Inhalation)	Preferred Pharmaceuticals Inc.	68788-8429