What is NDC 71610-450?

71610-450 is the product NDC for Febuxostat, Febuxostat 40 mg/1 tablet, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Febuxostat NDC 71610-450 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)71610-450Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71610-0450Add 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	Copy
71610-450-60	7161004506071610045060	90 TABLET in 1 BOTTLE (71610-450-60)Marketed from Jul 29, 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 — 40 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 71610
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 205414
Marketing start: Nov 11, 2019
Listing expires: Dec 31, 2026
Other FDA classes: Xanthine Oxidase Inhibitors (Mechanism)
Identifiers: Product ID 71610-450_7d2d6969-3ebd-4a87-9e40-407f5d86fd65SPL ID 7d2d6969-3ebd-4a87-9e40-407f5d86fd65SPL set ID bc986925-fd24-4865-997c-ede55c2faffcRxCUI 834235UNII 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

N471610045060 followed by a unit qualifier and the quantity

Package 71610-0450-60. 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 Aug 4, 2020. 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. 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 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 d…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71610-450

What is NDC 71610-450?: 71610-450 is the product NDC for Febuxostat, Febuxostat 40 mg/1 tablet, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. 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?: Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
febuxostat	Febuxostat 40 mg/1	TabletOral	REMEDYREPACK INC.	70518-4626	70518-4626-00
Febuxostat	Febuxostat 80 mg/1	TabletOral	HEC Pharm USA Inc.	72303-0856	72303-0856-01
Febuxostat	Febuxostat 40 mg/1	TabletOral	HEC Pharm USA Inc.	72303-0855	72303-0855-01
Febuxostat	Febuxostat 40 mg/1	TabletOral	Aurobindo Pharma Limited	59651-113	59651-0113-0559651-0113-3059651-0113-90
Febuxostat	Febuxostat 80 mg/1	TabletOral	Aurobindo Pharma Limited	59651-114	59651-0114-0159651-0114-0559651-0114-30+1 more
Febuxostat	Febuxostat 40 mg/1	TabletOral	Solco Healthcare US LLC	43547-295	43547-0295-0343547-0295-0943547-0295-50
Febuxostat	Febuxostat 80 mg/1	TabletOral	Solco Healthcare US LLC	43547-296	43547-0296-0343547-0296-0943547-0296-50
febuxostat	Febuxostat 80 mg/1	TabletOral	Zydus Lifesciences Limited	70771-1553	70771-1553-0070771-1553-0170771-1553-03+3 more
febuxostat	Febuxostat 40 mg/1	TabletOral	Zydus Lifesciences Limited	70771-1552	70771-1552-0070771-1552-0170771-1552-03+3 more
febuxostat	Febuxostat 40 mg/1	TabletOral	Viona Pharmaceuticals Inc	72578-136	72578-0136-0172578-0136-0572578-0136-06+3 more

All 43 Febuxostat NDCs

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
Product	Strength	Form · route	Labeler	Product NDC
Febuxostat	Febuxostat 40 mg/1	TabletOral	Hikma Pharmaceuticals USA Inc	0054-0413
Febuxostat	Febuxostat 80 mg/1	TabletOral	Hikma Pharmaceuticals USA Inc	0054-0414
Febuxostat	Febuxostat 40 mg/1	TabletOral	Golden State Medical Supply, Inc.	51407-293
Febuxostat	Febuxostat 80 mg/1	TabletOral	Golden State Medical Supply, Inc.	51407-294