Febuxostat NDC 0054-0413

NDC codes

FDA NDC Directory

Product NDC (as listed)0054-0413Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00054-0413Add 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
0054-0413-13	00054041313	30 TABLET in 1 BOTTLE (0054-0413-13)Marketed from Nov 11, 2019

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): Febuxostat
Generic name (nonproprietary): febuxostat
Active ingredients: Febuxostat — 40 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Hikma Pharmaceuticals USA Inc
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 205414
Marketing start: Nov 11, 2019
Listing expires: Dec 31, 2026
Other FDA classes: Xanthine Oxidase Inhibitors (Mechanism)
Identifiers: Product ID 0054-0413_bbddff32-f902-4e38-94fb-a1b903d69ee8SPL ID bbddff32-f902-4e38-94fb-a1b903d69ee8SPL set ID 14f1555c-2565-42c7-b3f5-dd5f03fed67aRxCUI 834235, 834241UNII 101V0R1N2E
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

N400054041313 followed by a unit qualifier and the quantity

Package 00054-0413-13. 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 May 31, 2023. This label includes a boxed warning.

Indications (excerpt from the label)

Febuxostat Tablets are a 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. Limitations of Use: Febuxostat Tablets are not recommended for the treatment of asymptomatic hyperuricemia. Febuxostat Tablets are a 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 allopu…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 205414

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

FDA NDC Directory listings under ANDA 205414
Product	Strength	Form · route	Labeler	Product NDC
Febuxostat	Febuxostat 40 mg/1	TabletOral	Golden State Medical Supply, Inc.	51407-293
Febuxostat	Febuxostat 80 mg/1	TabletOral	Golden State Medical Supply, Inc.	51407-294
Febuxostat	Febuxostat 80 mg/1	TabletOral	Hikma Pharmaceuticals USA Inc	0054-0414
Febuxostat	Febuxostat 40 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	71610-450