budesonide NDC 0904-7313

NDC codes

FDA NDC Directory

Product NDC (as listed)0904-7313Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00904-7313Add 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
0904-7313-10	00904731310	20 BLISTER PACK in 1 CARTON (0904-7313-10) / 1 CAPSULE, COATED PELLETS in 1 BLISTER PACKMarketed from Sep 3, 2024

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 — 3 mg/1
Dosage form: Capsule, Coated pellets
Route: Oral
Labeler: Major Pharmaceuticals
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 206134
Marketing start: Sep 3, 2024
Listing expires: Dec 31, 2026
Other FDA classes: Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers: Product ID 0904-7313_cb9e8049-c3d3-466e-bf9c-3c5032030f4eSPL ID cb9e8049-c3d3-466e-bf9c-3c5032030f4eSPL set ID e7aca8d1-159e-4aac-b92d-3a69a8edceecRxCUI 1244214UNII 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

N400904731310 followed by a unit qualifier and the quantity

Package 00904-7313-10. 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 Mar 10, 2025.

Indications (excerpt from the label)

Budesonide delayed-release capsules are corticosteroid indicated for: • Treatment of mild to moderate active Crohn's disease involving the ileum and/or the ascending colon, in patients 8 years and older. ( 1.1 ) • Maintenance of clinical remission of mild to moderate Crohn's disease involving the ileum and/or the ascending colon for up to 3 months in adults. ( 1.2 ) 1.1 Treatment of Mild to Moderate Active Crohn’s Disease Budesonide delayed-release capsules are indicated for the treatment of mild to moderate active Crohn's disease involving the ileum and/or the ascending colon in patients 8 years of age and older. 1.2 Maintenance of Clinical Remission of Mild to Moderate Crohn’s Disease Bude…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 206134

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

FDA NDC Directory listings under ANDA 206134
Product	Strength	Form · route	Labeler	Product NDC
budesonide	Budesonide 3 mg/1	Capsule, Coated pelletsOral	Zydus Lifesciences Limited	70771-1075
budesonide	Budesonide 3 mg/1	Capsule, Coated pelletsOral	Northstar Rx LLC.	16714-829
Budesonide	Budesonide 3 mg/1	Capsule, Coated pelletsOral	American Health Packaging	60687-596
budesonide	Budesonide 3 mg/1	Capsule, Coated pelletsOral	Zydus Pharmaceuticals USA Inc.	68382-720
budesonide	Budesonide 3 mg/1	Capsule, Coated pelletsOral	REMEDYREPACK INC.	70518-4613