Febuxostat NDC 55111-797

NDC codes

FDA NDC Directory

Product NDC (as listed)55111-797Labeler and product segments. Claims need a package NDC.

Product NDC at billing width55111-0797Add 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
55111-797-01	55111079701	100 TABLET in 1 BOTTLE (55111-797-01)Marketed from Nov 25, 2020
55111-797-05	55111079705	500 TABLET in 1 BOTTLE (55111-797-05)Marketed from Nov 25, 2020
55111-797-30	55111079730	30 TABLET in 1 BOTTLE (55111-797-30)Marketed from Nov 25, 2020
55111-797-90	55111079790	90 TABLET in 1 BOTTLE (55111-797-90)Marketed from Nov 25, 2020

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): Febuxostat
Generic name (nonproprietary): febuxostat
Active ingredients: Febuxostat — 80 mg/1
Dosage form: Tablet
Route: Oral
Labeler: DR REDDY'S LABORATORIES LIMITED
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 205374
Marketing start: Nov 25, 2020
Listing expires: Dec 31, 2026
Other FDA classes: Xanthine Oxidase Inhibitors (Mechanism)
Identifiers: Product ID 55111-797_25711455-9482-c211-793c-6d09539f1c09SPL ID 25711455-9482-c211-793c-6d09539f1c09SPL set ID ccf2c4b1-e9a3-c7b7-ac42-79e1988fc211RxCUI 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

N455111079701 followed by a unit qualifier and the quantity

Package 55111-0797-01. 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 Sep 18, 2019. This label includes a boxed warning.

Indications (excerpt from the label)

Febuxostat tablet is 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. For the safe and effective use of allopurinol, see allopurinol prescribing information. Limitations of Use: Febuxostat tablets are not recommended for the treatment of asymptomatic hyperuricemia. Febuxostat tablet is 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 …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 205374

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

FDA NDC Directory listings under ANDA 205374
Product	Strength	Form · route	Labeler	Product NDC
Febuxostat	Febuxostat 40 mg/1	TabletOral	DR REDDY'S LABORATORIES LIMITED	55111-796