Prescription drug · ANDA
Febuxostat NDC 0527-2244
Febuxostat 40 mg/1 · Tablet · Oral · Lannett Company, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0527-2244-32 | 00527224432 | 30 TABLET in 1 BOTTLE (0527-2244-32)Marketed from Jun 2, 2020 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
- Labeler
- Lannett Company, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213069
- Marketing start
- Listing expires
- Other FDA classes
- Xanthine Oxidase Inhibitors (Mechanism)
- Identifiers
- Product ID 0527-2244_0f0d0dad-f491-e7e1-e063-6294a90a1e13SPL ID 0f0d0dad-f491-e7e1-e063-6294a90a1e13SPL set ID 73b07a94-c044-42dc-abe4-7d7c860c9638RxCUI 834235, 834241UNII 101V0R1N2EUPC 0305272248328
- 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
N400527224432followed by a unit qualifier and the quantityPackage 00527-2244-32. 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 tablet 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. Febuxostat tablet 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. ( 1 ) Limitations of Use : Febuxostat tablets are not recommended for the treatment of a…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 213069
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 | TabletOral | Lannett Company, Inc. | 0527-2248 |
| Febuxostat | Febuxostat 40 mg/1 | TabletOral | HEC Pharm USA Inc. | 72303-0855 |
| Febuxostat | Febuxostat 80 mg/1 | TabletOral | HEC Pharm USA Inc. | 72303-0856 |