NDC codes

FDA NDC Directory
Product NDC (as listed)33342-274Labeler and product segments. Claims need a package NDC.
Product NDC at billing width33342-0274Add 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
33342-274-073334202740730 FILM in 1 BOTTLE (33342-274-07)Marketed from Apr 4, 2019
33342-274-103334202741090 FILM in 1 BOTTLE (33342-274-10)Marketed from Apr 4, 2019
33342-274-1533342027415500 FILM in 1 BOTTLE (33342-274-15)Marketed from Apr 4, 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 tablets 40 mg
Active ingredients
Febuxostat — 40 mg/1
Dosage form
Film
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 207293
Marketing start
Listing expires
Other FDA classes
Xanthine Oxidase Inhibitors (Mechanism)
Identifiers
Product ID 33342-274_eb38172a-f884-4a94-be6d-73ad338fb29cSPL ID eb38172a-f884-4a94-be6d-73ad338fb29cSPL set ID 77875ed1-049e-421b-a8d5-569b4af4a1b5RxCUI 834235, 834241UNII 101V0R1N2EUPC 0333342275073, 0333342274076, 0333342275103, 0333342274106, 0333342274151, 0333342275158
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

N433342027407 followed by a unit qualifier and the quantity

Package 33342-0274-07. 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 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. Limitations of Use: Febuxostat is not recommended for the treatment of asymptomatic hyperuricemia. Febuxostat tablets 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 advisa…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 207293

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

FDA NDC Directory listings under ANDA 207293
ProductStrengthForm · routeLabelerProduct NDC
Febuxostatfebuxostat tablets 80 mgFebuxostat 80 mg/1FilmOralMacleods Pharmaceuticals Limited33342-275

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