Prescription drug · ANDA
Febuxostat NDC 46708-191
Febuxostat 80 mg/1 · Tablet, Coated · Oral · Alembic Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 46708-191-06 | 46708019106 | 60 TABLET, COATED in 1 CARTON (46708-191-06)Marketed from Jul 1, 2019 | |
| 46708-191-10 | 46708019110 | 100 TABLET, COATED in 1 CARTON (46708-191-10)Marketed from Jul 1, 2019 | |
| 46708-191-30 | 46708019130 | 30 TABLET, COATED in 1 BOTTLE (46708-191-30)Marketed from Jul 1, 2019 | |
| 46708-191-31 | 46708019131 | 100 TABLET, COATED in 1 BOTTLE (46708-191-31)Marketed from Jul 1, 2019 | |
| 46708-191-91 | 46708019191 | 1000 TABLET, COATED in 1 BOTTLE (46708-191-91)Marketed from Jul 1, 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
- Active ingredients
- Febuxostat — 80 mg/1
- Dosage form
- Tablet, Coated
- Route
- Oral
- Labeler
- Alembic Pharmaceuticals LimitedNDC labeler code 46708
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205421
- Marketing start
- Listing expires
- Other FDA classes
- Xanthine Oxidase Inhibitors (Mechanism)
- Identifiers
- Product ID 46708-191_1d0ffd95-5afe-4f03-8ac9-706187144e98SPL ID 1d0ffd95-5afe-4f03-8ac9-706187144e98SPL set ID 41a95424-046e-413b-a121-cd7335e67135RxCUI 834235, 834241UNII 101V0R1N2E
- 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
N446708019106followed by a unit qualifier and the quantityPackage 46708-0191-06. 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. For the safe and effective use of allopurinol, see allopurinol prescribing information. Limitations of Use : Febuxostat tablets are not recommended for the treatment of asymptomatic hyperuricemia. 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…
Excerpt only. Read the full label for complete information.
About NDC 46708-191
- What is NDC 46708-191?
- 46708-191 is the product NDC for Febuxostat, Febuxostat 80 mg/1 tablet, coated, listed with the FDA by Alembic Pharmaceuticals Limited. It has 5 package NDCs, 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?
- Alembic Pharmaceuticals Limited, NDC labeler code 46708. 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 40 mg/1 | TabletOral | HEC Pharm USA Inc. | 72303-0855 | 72303-0855-01 |
| Febuxostat | Febuxostat 80 mg/1 | TabletOral | HEC Pharm USA Inc. | 72303-0856 | 72303-0856-01 |
| 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 40 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3760 | 68071-3760-09 |
| febuxostat | Febuxostat 40 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1552 | 70771-1552-0070771-1552-0170771-1552-03+3 more |
| febuxostat | Febuxostat 80 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1553 | 70771-1553-0070771-1553-0170771-1553-03+3 more |
Other NDCs under ANDA 205421
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 | Tablet, CoatedOral | Alembic Pharmaceuticals Limited | 46708-190 |
| Febuxostat | Febuxostat 80 mg/1 | Tablet, CoatedOral | Alembic Pharmaceuticals Inc. | 62332-191 |
| Febuxostat | Febuxostat 40 mg/1 | Tablet, CoatedOral | Alembic Pharmaceuticals Inc. | 62332-190 |