Budesonide NDC 0591-2510

NDC codes

FDA NDC Directory

Product NDC (as listed)0591-2510Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00591-2510Add 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
0591-2510-30	00591251030	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0591-2510-30)Marketed from Jul 5, 2018

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
Generic name (nonproprietary): budesonide
Active ingredients: Budesonide — 9 mg/1
Dosage form: Tablet, Film coated, Extended release
Route: Oral
Labeler: Actavis Pharma, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 205457
Marketing start: Jul 5, 2018
Listing expires: Dec 31, 2026
Other FDA classes: Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers: Product ID 0591-2510_5b1c0fe2-b58d-43b4-8784-038653663c44SPL ID 5b1c0fe2-b58d-43b4-8784-038653663c44SPL set ID 41d4fd39-81ee-41be-b34d-efb12b3a359dRxCUI 1366550UNII Q3OKS62Q6XUPC 0305912510303
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

N400591251030 followed by a unit qualifier and the quantity

Package 00591-2510-30. 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 Jun 20, 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)