Febuxostat NDC 68071-5271

NDC codes

FDA NDC Directory

Product NDC (as listed)68071-5271Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68071-5271Add 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
68071-5271-3	68071527103	30 TABLET, FILM COATED in 1 BOTTLE (68071-5271-3)Marketed from Jun 4, 2020

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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): Febuxostat
Generic name (nonproprietary): febuxostat
Active ingredients: Febuxostat — 40 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: NuCare Pharmaceuticals,Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 210461
Marketing start: Dec 30, 2019
Listing expires: Dec 31, 2026
Other FDA classes: Xanthine Oxidase Inhibitors (Mechanism)
Identifiers: Product ID 68071-5271_1d7908f6-b143-36ea-e063-6394a90a4cbbSPL ID 1d7908f6-b143-36ea-e063-6394a90a4cbbSPL set ID a745be75-4fa5-cbf9-e053-2995a90a3a81RxCUI 834235UNII 101V0R1N2EUPC 0368071527131
Pharmacologic class: Xanthine Oxidase Inhibitor

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

N468071527103 followed by a unit qualifier and the quantity

Package 68071-5271-03. 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 Jul 17, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

Febuxostat tablets are xanthine oxidase (XO) inhibitor indicated for the chronic management of hyperuricemia in adult patients with gout who have an inadequate response to a maximally titrated dose of allopurinol, who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable. Febuxostat tablets are not recommended for the treatment of asymptomatic hyperuricemia. Febuxostat tablets are xanthine oxidase (XO) inhibitor indicated for the chronic management of hyperuricemia in adult patients with gout who have an inadequate response to a maximally titrated dose of allopurinol, who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable. …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 210461

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

FDA NDC Directory listings under ANDA 210461
Product	Strength	Form · route	Labeler	Product NDC
Febuxostat	Febuxostat 40 mg/1	Tablet, Film coatedOral	MAJOR PHARMACEUTICALS	0904-7395
Febuxostat	Febuxostat 80 mg/1	Tablet, Film coatedOral	MAJOR PHARMACEUTICALS	0904-7396
Febuxostat	Febuxostat 40 mg/1	Tablet, Film coatedOral	Novadoz Pharmaceuticals LLC	72205-028
Febuxostat	Febuxostat 80 mg/1	Tablet, Film coatedOral	Novadoz Pharmaceuticals LLC	72205-029
Febuxostat	Febuxostat 40 mg/1	Tablet, Film coatedOral	Aphena Pharma Solutions - Tennessee, LLC	71610-411