Prescription drug · ANDA
Febuxostat (febuxostat tablets 40 mg) NDC 33342-274
Febuxostat 40 mg/1 · Film · Oral · Macleods Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 33342-274-07 | 33342027407 | 30 FILM in 1 BOTTLE (33342-274-07)Marketed from Apr 4, 2019 | |
| 33342-274-10 | 33342027410 | 90 FILM in 1 BOTTLE (33342-274-10)Marketed from Apr 4, 2019 | |
| 33342-274-15 | 33342027415 | 500 FILM in 1 BOTTLE (33342-274-15)Marketed from Apr 4, 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 tablets 40 mg
- Active ingredients
- Febuxostat — 40 mg/1
- Dosage form
- Film
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207293
- Marketing start
- Listing expires
- Other FDA classes
- Xanthine Oxidase Inhibitors (Mechanism)
- Identifiers
- Product ID 33342-274_eb38172a-f884-4a94-be6d-73ad338fb29cSPL ID eb38172a-f884-4a94-be6d-73ad338fb29cSPL set ID 77875ed1-049e-421b-a8d5-569b4af4a1b5RxCUI 834235, 834241UNII 101V0R1N2EUPC 0333342275073, 0333342274076, 0333342275103, 0333342274106, 0333342274151, 0333342275158
- 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
N433342027407followed by a unit qualifier and the quantityPackage 33342-0274-07. 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 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 not advisable. Limitations of Use: Febuxostat is not recommended for the treatment of asymptomatic hyperuricemia. Febuxostat tablets 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 not advisa…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 207293
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 |
|---|---|---|---|---|
| Febuxostatfebuxostat tablets 80 mg | Febuxostat 80 mg/1 | FilmOral | Macleods Pharmaceuticals Limited | 33342-275 |