budesonide NDC 68682-658

NDC codes

FDA NDC Directory

Product NDC (as listed)68682-658Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68682-0658Add 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
68682-658-03	68682065803	2 CANISTER in 1 CARTON (68682-658-03) / 1 AEROSOL, FOAM in 1 CANISTER (68682-658-02)Marketed from Jul 15, 2022

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: Oceanside Pharmaceuticals
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 205613
Marketing start: Jul 15, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers: Product ID 68682-658_cfc0acf9-28d8-4404-81ec-c832914d2ea6SPL ID cfc0acf9-28d8-4404-81ec-c832914d2ea6SPL set ID b2cf85c5-3ae0-4f91-9f3a-1d6771e14a73RxCUI 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

N468682065803 followed by a unit qualifier and the quantity

Package 68682-0658-03. 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 Oct 1, 2021.

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. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 205613

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

FDA NDC Directory listings under NDA 205613
Product	Strength	Form · route	Labeler	Product NDC
Ucerisbudesonide	Budesonide 2 mg/1	Aerosol, FoamRectal	Salix Pharmaceuticals, Inc.	65649-651