Budesonide NDC 45802-627

NDC codes

FDA NDC Directory

Product NDC (as listed)45802-627Labeler and product segments. Claims need a package NDC.

Product NDC at billing width45802-0627Add 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
45802-627-86	45802062786	2 CANISTER in 1 CARTON (45802-627-86) / 1 AEROSOL, FOAM in 1 CANISTER (45802-627-01)Marketed from Apr 17, 2023

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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
Generic name (nonproprietary): budesonide
Active ingredients: Budesonide — 2 mg/1
Dosage form: Aerosol, Foam
Route: Rectal
Labeler: Padagis Israel Pharmaceuticals Ltd
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 215328
Marketing start: Apr 17, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers: Product ID 45802-627_ad4a68e7-9200-4f05-8058-714d5d8900f8SPL ID ad4a68e7-9200-4f05-8058-714d5d8900f8SPL set ID ad4a68e7-9200-4f05-8058-714d5d8900f8RxCUI 1596779UNII Q3OKS62Q6X
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

N445802062786 followed by a unit qualifier and the quantity

Package 45802-0627-86. 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 Apr 17, 2023.

Indications (excerpt from the label)

Budesonide rectal foam is indicated for the induction of remission in patients with active mild to moderate distal ulcerative colitis extending up to 40 cm from the anal verge. Budesonide rectal foam is a glucocorticosteroid indicated for the induction of remission in patients with active mild to moderate distal ulcerative colitis extending up to 40 cm from the anal verge.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)