What is NDC 0904-7395?

0904-7395 is the product NDC for Febuxostat, Febuxostat 40 mg/1 tablet, film coated, listed with the FDA by MAJOR PHARMACEUTICALS. It has 1 package NDC, shown above in 10- and 11-digit form.

MAJOR PHARMACEUTICALS, NDC labeler code 0904. 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 0904-7395 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0904-7395Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00904-7395Add 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
0904-7395-46	0090473954600904739546	30 TABLET, FILM COATED in 1 BOTTLE (0904-7395-46)Marketed from Dec 1, 2023

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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, Film coated
Route: Oral
Labeler: MAJOR PHARMACEUTICALSNDC labeler code 0904
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 210461
Marketing start: Dec 30, 2019
Listing expires: Dec 31, 2027
Other FDA classes: Xanthine Oxidase Inhibitors (Mechanism)
Identifiers: Product ID 0904-7395_2a8a681c-a419-43c5-b5ba-f6596aeb6677SPL ID 2a8a681c-a419-43c5-b5ba-f6596aeb6677SPL set ID 13a80059-46f7-4453-ab37-72744657a08aRxCUI 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

N400904739546 followed by a unit qualifier and the quantity

Package 00904-7395-46. 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 Jun 4, 2024. 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 allopurino…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0904-7395

What is NDC 0904-7395?: 0904-7395 is the product NDC for Febuxostat, Febuxostat 40 mg/1 tablet, film coated, listed with the FDA by MAJOR PHARMACEUTICALS. 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?: MAJOR PHARMACEUTICALS, NDC labeler code 0904. 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 210461

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

FDA NDC Directory listings under ANDA 210461
Product	Strength	Form · route	Labeler	Product NDC
Febuxostat	Febuxostat 80 mg/1	Tablet, Film coatedOral	MAJOR PHARMACEUTICALS	0904-7396
Febuxostat	Febuxostat 40 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals,Inc.	68071-5271
Febuxostat	Febuxostat 40 mg/1	Tablet, Film coatedOral	Aphena Pharma Solutions - Tennessee, LLC	71610-411
Febuxostat	Febuxostat 40 mg/1	Tablet, Film coatedOral	Novadoz Pharmaceuticals LLC	72205-028
Febuxostat	Febuxostat 80 mg/1	Tablet, Film coatedOral	Novadoz Pharmaceuticals LLC	72205-029