NDC codes

FDA NDC Directory
Product NDC (as listed)64764-677Labeler and product segments. Claims need a package NDC.
Product NDC at billing width64764-0677Add 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 NDC11-digit (billing)PackageCopy
64764-677-116476406771110 BLISTER PACK in 1 CARTON (64764-677-11) / 10 TABLET in 1 BLISTER PACKMarketed from Feb 13, 2009
64764-677-1364764067713100 TABLET in 1 BOTTLE (64764-677-13)Marketed from Feb 13, 2009
64764-677-19647640677191000 TABLET in 1 BOTTLE (64764-677-19)Marketed from Feb 13, 2009
64764-677-306476406773030 TABLET in 1 BOTTLE (64764-677-30)Marketed from Feb 13, 2009

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)
Uloric
Generic name (nonproprietary)
febuxostat
Active ingredients
Febuxostat — 80 mg/1
Dosage form
Tablet
Route
Oral
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 021856
Marketing start
Listing expires
Other FDA classes
Xanthine Oxidase Inhibitors (Mechanism)
Identifiers
Product ID 64764-677_16c36a5a-2f72-4df7-aa6f-1ca27a39404fSPL ID 16c36a5a-2f72-4df7-aa6f-1ca27a39404fSPL set ID 54de10ef-fe5f-4930-b91d-6bbb04c664bdRxCUI 834235, 834239, 834241, 834243UNII 101V0R1N2EUPC 0364764677305
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

N464764067711 followed by a unit qualifier and the quantity

Package 64764-0677-11. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

ULORIC 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. ULORIC 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. ( 1 ) Limitations of Use : ULORIC is not recommended for the treatment of asymptomatic hyperuricemia. ( 1 ) Li…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 021856

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

FDA NDC Directory listings under NDA 021856
ProductStrengthForm · routeLabelerProduct NDC
UloricfebuxostatFebuxostat 40 mg/1TabletOralTakeda Pharmaceuticals America, Inc.64764-918

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