Prescription drug · ANDA
Febuxostat NDC 47335-722
Febuxostat 80 mg/1 · Tablet, Film coated · Oral · Sun Pharmaceutical Industries, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 47335-722-18 | 47335072218 | 1000 TABLET, FILM COATED in 1 BOTTLE (47335-722-18)Marketed from Jul 5, 2019 | |
| 47335-722-83 | 47335072283 | 30 TABLET, FILM COATED in 1 BOTTLE (47335-722-83)Marketed from Jul 5, 2019 | |
| 47335-722-88 | 47335072288 | 100 TABLET, FILM COATED in 1 BOTTLE (47335-722-88)Marketed from Jul 5, 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, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205467
- Marketing start
- Listing expires
- Other FDA classes
- Xanthine Oxidase Inhibitors (Mechanism)
- Identifiers
- Product ID 47335-722_53dfe063-e9bf-4069-b4cc-5a83a27d18ecSPL ID 53dfe063-e9bf-4069-b4cc-5a83a27d18ecSPL set ID 1f7541bd-bf32-422b-b99a-89193cf193caRxCUI 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
N447335072218followed by a unit qualifier and the quantityPackage 47335-0722-18. 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 is 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 no…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 205467
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Febuxostat | Febuxostat 40 mg/1 | Tablet, Film coatedOral | NorthStar RxLLC | 16714-059 |
| Febuxostat | Febuxostat 80 mg/1 | Tablet, Film coatedOral | NorthStar RxLLC | 16714-060 |
| Febuxostat | Febuxostat 40 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-538 |
| Febuxostat | Febuxostat 40 mg/1 | Tablet, Film coatedOral | Sun Pharmaceutical Industries, Inc. | 47335-721 |
| Febuxostat | Febuxostat 80 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals, Inc. | 68071-3761 |