Prescription drug · ANDA
Febuxostat NDC 71610-450
Febuxostat 40 mg/1 · Tablet · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71610-450-60 | 71610045060 | 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
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205414
- Marketing start
- Listing expires
- 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
N471610045060followed by a unit qualifier and the quantityPackage 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 . 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.
Other NDCs under ANDA 205414
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 | TabletOral | Hikma Pharmaceuticals USA Inc | 0054-0413 |
| 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 |
| Febuxostat | Febuxostat 80 mg/1 | TabletOral | Hikma Pharmaceuticals USA Inc | 0054-0414 |