NDC codes

FDA NDC Directory
Product NDC (as listed)27808-207Labeler and product segments. Claims need a package NDC.
Product NDC at billing width27808-0207Add 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
27808-207-012780802070130 TABLET in 1 BOTTLE (27808-207-01)Marketed from Sep 28, 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
Tris Pharma IncNDC labeler code 27808
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 210292
Marketing start
Listing expires
Other FDA classes
Xanthine Oxidase Inhibitors (Mechanism)
Identifiers
Product ID 27808-207_7a3e937f-5938-4fa5-87da-3cbf111e582eSPL ID 7a3e937f-5938-4fa5-87da-3cbf111e582eSPL set ID d3b18653-9487-4a78-82c0-80ee024b8ef6RxCUI 834235, 834241UNII 101V0R1N2EUPC 0327808207012, 0327808206015
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

N427808020701 followed by a unit qualifier and the quantity

Package 27808-0207-01. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

Febuxostat tablets are 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 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 allopurin…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 27808-207

What is NDC 27808-207?
27808-207 is the product NDC for Febuxostat, Febuxostat 80 mg/1 tablet, listed with the FDA by Tris Pharma Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Febuxostat.
What is the active ingredient?
Febuxostat.
Who is the labeler?
Tris Pharma Inc, NDC labeler code 27808. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Febuxostat?
42 other product NDCs are listed under this name. See all Febuxostat NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Febuxostat NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
febuxostatFebuxostat 40 mg/1TabletOralREMEDYREPACK INC.70518-462670518-4626-00
FebuxostatFebuxostat 40 mg/1TabletOralHEC Pharm USA Inc.72303-085572303-0855-01
FebuxostatFebuxostat 80 mg/1TabletOralHEC Pharm USA Inc.72303-085672303-0856-01
FebuxostatFebuxostat 40 mg/1TabletOralAurobindo Pharma Limited59651-11359651-0113-0559651-0113-3059651-0113-90
FebuxostatFebuxostat 80 mg/1TabletOralAurobindo Pharma Limited59651-11459651-0114-0159651-0114-0559651-0114-30+1 more
FebuxostatFebuxostat 40 mg/1TabletOralSolco Healthcare US LLC43547-29543547-0295-0343547-0295-0943547-0295-50
FebuxostatFebuxostat 80 mg/1TabletOralSolco Healthcare US LLC43547-29643547-0296-0343547-0296-0943547-0296-50
febuxostatFebuxostat 40 mg/1TabletOralNuCare Pharmaceuticals, Inc.68071-376068071-3760-09
febuxostatFebuxostat 40 mg/1TabletOralZydus Lifesciences Limited70771-155270771-1552-0070771-1552-0170771-1552-03+3 more
febuxostatFebuxostat 80 mg/1TabletOralZydus Lifesciences Limited70771-155370771-1553-0070771-1553-0170771-1553-03+3 more

All 43 Febuxostat NDCs

Other NDCs under ANDA 210292

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

FDA NDC Directory listings under ANDA 210292
ProductStrengthForm · routeLabelerProduct NDC
FebuxostatFebuxostat 40 mg/1TabletOralTris Pharma Inc27808-206

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