Prescription drug · ANDA
Febuxostat NDC 16714-059
Febuxostat 40 mg/1 · Tablet, Film coated · Oral · NorthStar RxLLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16714-059-01 | 1671400590116714005901 | 30 TABLET, FILM COATED in 1 BOTTLE (16714-059-01)Marketed from Jan 26, 2021 |
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, Film coated
- Route
- Oral
- Labeler
- NorthStar RxLLCNDC labeler code 16714
- 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 16714-059_0284b7a5-7a1f-4e37-9883-b7bdba68c42bSPL ID 0284b7a5-7a1f-4e37-9883-b7bdba68c42bSPL set ID ad40e0f6-850c-429a-87fc-f1eb2361e962RxCUI 834235, 834241UNII 101V0R1N2EUPC 0316714060019
- 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
N416714005901followed by a unit qualifier and the quantityPackage 16714-0059-01. 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. 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 n…
Excerpt only. Read the full label for complete information.
About NDC 16714-059
- What is NDC 16714-059?
- 16714-059 is the product NDC for Febuxostat, Febuxostat 40 mg/1 tablet, film coated, listed with the FDA by NorthStar RxLLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Febuxostat.
- What is the active ingredient?
- Febuxostat.
- Who is the labeler?
- NorthStar RxLLC, NDC labeler code 16714. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Febuxostat?
- 42 other product NDCs are listed under this name. See all Febuxostat NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Febuxostat products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| febuxostat | Febuxostat 40 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4626 | 70518-4626-00 |
| Febuxostat | Febuxostat 80 mg/1 | TabletOral | HEC Pharm USA Inc. | 72303-0856 | 72303-0856-01 |
| Febuxostat | Febuxostat 40 mg/1 | TabletOral | HEC Pharm USA Inc. | 72303-0855 | 72303-0855-01 |
| Febuxostat | Febuxostat 40 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-113 | 59651-0113-0559651-0113-3059651-0113-90 |
| Febuxostat | Febuxostat 80 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-114 | 59651-0114-0159651-0114-0559651-0114-30+1 more |
| Febuxostat | Febuxostat 40 mg/1 | TabletOral | Solco Healthcare US LLC | 43547-295 | 43547-0295-0343547-0295-0943547-0295-50 |
| Febuxostat | Febuxostat 80 mg/1 | TabletOral | Solco Healthcare US LLC | 43547-296 | 43547-0296-0343547-0296-0943547-0296-50 |
| febuxostat | Febuxostat 80 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1553 | 70771-1553-0070771-1553-0170771-1553-03+3 more |
| febuxostat | Febuxostat 40 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1552 | 70771-1552-0070771-1552-0170771-1552-03+3 more |
| febuxostat | Febuxostat 40 mg/1 | TabletOral | Viona Pharmaceuticals Inc | 72578-136 | 72578-0136-0172578-0136-0572578-0136-06+3 more |
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 80 mg/1 | Tablet, Film coatedOral | NorthStar RxLLC | 16714-060 |
| Febuxostat | Febuxostat 40 mg/1 | Tablet, Film coatedOral | Sun Pharmaceutical Industries, Inc. | 47335-721 |
| Febuxostat | Febuxostat 80 mg/1 | Tablet, Film coatedOral | Sun Pharmaceutical Industries, Inc. | 47335-722 |
| Febuxostat | Febuxostat 40 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-538 |
| Febuxostat | Febuxostat 80 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals, Inc. | 68071-3761 |