Febuxostat NDC 46708-190

NDC codes

FDA NDC Directory

Product NDC (as listed)46708-190Labeler and product segments. Claims need a package NDC.

Product NDC at billing width46708-0190Add 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
46708-190-08	46708019008	80 TABLET, COATED in 1 CARTON (46708-190-08)Marketed from Jul 1, 2019
46708-190-10	46708019010	100 TABLET, COATED in 1 CARTON (46708-190-10)Marketed from Jul 1, 2019
46708-190-30	46708019030	30 TABLET, COATED in 1 BOTTLE (46708-190-30)Marketed from Jul 1, 2019
46708-190-31	46708019031	100 TABLET, COATED in 1 BOTTLE (46708-190-31)Marketed from Jul 1, 2019
46708-190-91	46708019091	1000 TABLET, COATED in 1 BOTTLE (46708-190-91)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 — 40 mg/1
Dosage form: Tablet, Coated
Route: Oral
Labeler: Alembic Pharmaceuticals Limited
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 46708-190_1d0ffd95-5afe-4f03-8ac9-706187144e98SPL ID 1d0ffd95-5afe-4f03-8ac9-706187144e98SPL set ID 41a95424-046e-413b-a121-cd7335e67135RxCUI 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

N446708019008 followed by a unit qualifier and the quantity

Package 46708-0190-08. 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 Jan 19, 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. 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 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…

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 80 mg/1	Tablet, CoatedOral	Alembic Pharmaceuticals Limited	46708-191
Febuxostat	Febuxostat 80 mg/1	Tablet, CoatedOral	Alembic Pharmaceuticals Inc.	62332-191
Febuxostat	Febuxostat 40 mg/1	Tablet, CoatedOral	Alembic Pharmaceuticals Inc.	62332-190