Prescription drug · ANDA
febuxostat NDC 68071-3760
Febuxostat 40 mg/1 · Tablet · Oral · NuCare Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68071-3760-9 | 68071376009 | 90 TABLET in 1 BOTTLE (68071-3760-9)Marketed from Jan 10, 2025 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Labeler
- NuCare 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 68071-3760_2b5d52a3-c025-680f-e063-6394a90aca3fSPL ID 2b5d52a3-c025-680f-e063-6394a90aca3fSPL set ID 2b5d205f-30e3-33e6-e063-6394a90aa683RxCUI 834235UNII 101V0R1N2EUPC 0368071376098
- 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
N468071376009followed by a unit qualifier and the quantityPackage 68071-3760-09. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
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 80 mg/1 | TabletOral | Viona Pharmaceuticals Inc | 72578-137 |
| 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 |