budesonide NDC 68682-309

NDC codes

FDA NDC Directory

Product NDC (as listed)68682-309Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68682-0309Add 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
68682-309-30	68682030930	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68682-309-30)Marketed from Jul 10, 2018

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 — 9 mg/1
Dosage form: Tablet, Extended release
Route: Oral
Labeler: Oceanside Pharmaceuticals
Product type: Prescription drug
Marketing category: NDA authorized genericApplication NDA 203634
Marketing start: Jul 10, 2018
Listing expires: Dec 31, 2026
Other FDA classes: Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers: Product ID 68682-309_2553124a-3ed4-365d-e063-6294a90a4224SPL ID 2553124a-3ed4-365d-e063-6294a90a4224SPL set ID a12b2e99-c8b3-4d08-9af0-8c4a4376ebf1RxCUI 1366550UNII 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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N468682030930 followed by a unit qualifier and the quantity

Package 68682-0309-30. 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 25, 2024.

Indications (excerpt from the label)

Budesonide extended-release tablets are indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis. Budesonide extended-release tablets are a glucocorticosteroid indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 203634

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

FDA NDC Directory listings under NDA 203634
Product	Strength	Form · route	Labeler	Product NDC
Ucerisbudesonide	Budesonide 9 mg/1	Tablet, Extended releaseOral	Santarus Inc.	68012-309