Prescription drug · ANDA
febuxostat NDC 72578-137
Febuxostat 80 mg/1 · Tablet · Oral · Viona Pharmaceuticals Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72578-137-01 | 72578013701 | 100 TABLET in 1 BOTTLE (72578-137-01)Marketed from Mar 31, 2023 | |
| 72578-137-05 | 72578013705 | 500 TABLET in 1 BOTTLE (72578-137-05)Marketed from Mar 31, 2023 | |
| 72578-137-06 | 72578013706 | 30 TABLET in 1 BOTTLE (72578-137-06)Marketed from Mar 31, 2023 | |
| 72578-137-10 | 72578013710 | 1000 TABLET in 1 BOTTLE (72578-137-10)Marketed from Mar 31, 2023 | |
| 72578-137-16 | 72578013716 | 90 TABLET in 1 BOTTLE (72578-137-16)Marketed from Mar 31, 2023 | |
| 72578-137-77 | 72578013777 | 10 BLISTER PACK in 1 CARTON (72578-137-77) / 10 TABLET in 1 BLISTER PACKMarketed from Mar 31, 2023 |
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
- Route
- Oral
- Labeler
- Viona Pharmaceuticals Inc
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205443
- Marketing start
- Listing expires
- Other FDA classes
- Xanthine Oxidase Inhibitors (Mechanism)
- Identifiers
- Product ID 72578-137_082ca5b7-ccb9-4096-a363-a188d6f51586SPL ID 082ca5b7-ccb9-4096-a363-a188d6f51586SPL set ID b2aeb900-d792-48b2-b678-94f82d68be32RxCUI 834235, 834241UNII 101V0R1N2EUPC 0372578137069, 0372578136062
- 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
N472578013701followed by a unit qualifier and the quantityPackage 72578-0137-01. 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. ( 1 ) Limitations of Use: Febuxostat tablets are not recommended for the treatment of asymptomatic hyperuricemia. ( 1 ) 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 wit…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 205443
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 | Viona Pharmaceuticals Inc | 72578-136 |
| febuxostat | Febuxostat 40 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3760 |
| febuxostat | Febuxostat 40 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4626 |
| febuxostat | Febuxostat 40 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1552 |
| febuxostat | Febuxostat 80 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1553 |