Febuxostat NDC 62332-191

NDC codes

FDA NDC Directory

Product NDC (as listed)62332-191Labeler and product segments. Claims need a package NDC.

Product NDC at billing width62332-0191Add 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
62332-191-06	62332019106	60 TABLET, COATED in 1 CARTON (62332-191-06)Marketed from Jul 1, 2019
62332-191-10	62332019110	100 TABLET, COATED in 1 CARTON (62332-191-10)Marketed from Jul 1, 2019
62332-191-30	62332019130	30 TABLET, COATED in 1 BOTTLE (62332-191-30)Marketed from Jul 1, 2019
62332-191-31	62332019131	100 TABLET, COATED in 1 BOTTLE (62332-191-31)Marketed from Jul 1, 2019
62332-191-91	62332019191	1000 TABLET, COATED in 1 BOTTLE (62332-191-91)Marketed from Jul 1, 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, Coated
Route: Oral
Labeler: Alembic Pharmaceuticals Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 205421
Marketing start: Jul 1, 2019
Listing expires: Dec 31, 2026
Other FDA classes: Xanthine Oxidase Inhibitors (Mechanism)
Identifiers: Product ID 62332-191_d93f60e8-39b0-4359-9aaa-2e02ac188b1fSPL ID d93f60e8-39b0-4359-9aaa-2e02ac188b1fSPL set ID 9a87099f-d82d-42c7-872a-b87d3917e960RxCUI 834235, 834241UNII 101V0R1N2EUPC 0362332191307
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

N462332019106 followed by a unit qualifier and the quantity

Package 62332-0191-06. 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 Apr 27, 2023. 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)

Other NDCs under ANDA 205421

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

FDA NDC Directory listings under ANDA 205421
Product	Strength	Form · route	Labeler	Product NDC
Febuxostat	Febuxostat 40 mg/1	Tablet, CoatedOral	Alembic Pharmaceuticals Limited	46708-190
Febuxostat	Febuxostat 80 mg/1	Tablet, CoatedOral	Alembic Pharmaceuticals Limited	46708-191
Febuxostat	Febuxostat 40 mg/1	Tablet, CoatedOral	Alembic Pharmaceuticals Inc.	62332-190