NDC codes

FDA NDC Directory
Product NDC (as listed)51407-294Labeler and product segments. Claims need a package NDC.
Product NDC at billing width51407-0294Add 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
51407-294-305140702943030 TABLET in 1 BOTTLE (51407-294-30)Marketed from Nov 13, 2019

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
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 205414
Marketing start
Listing expires
Other FDA classes
Xanthine Oxidase Inhibitors (Mechanism)
Identifiers
Product ID 51407-294_15c4de3a-08ea-a228-e063-6394a90aafafSPL ID 15c4de3a-08ea-a228-e063-6394a90aafafSPL set ID 97a8c7fc-0a66-2ddc-e053-2a95a90ad313RxCUI 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

N451407029430 followed by a unit qualifier and the quantity

Package 51407-0294-30. 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)

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
ProductStrengthForm · routeLabelerProduct NDC
FebuxostatFebuxostat 40 mg/1TabletOralHikma Pharmaceuticals USA Inc0054-0413
FebuxostatFebuxostat 40 mg/1TabletOralGolden State Medical Supply, Inc.51407-293
FebuxostatFebuxostat 80 mg/1TabletOralHikma Pharmaceuticals USA Inc0054-0414
FebuxostatFebuxostat 40 mg/1TabletOralAphena Pharma Solutions - Tennessee, LLC71610-450

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