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NDC 62332-0191-91 Febuxostat 80 mg/1 Details
Febuxostat 80 mg/1
Febuxostat is a ORAL TABLET, COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Alembic Pharmaceuticals Inc.. The primary component is FEBUXOSTAT.
MedlinePlus Drug Summary
Febuxostat is used to treat gout in adults who were not treated successfully with or who are not able to take allopurinol (Aloprim, Zyloprim). Gout is a type of arthritis in which uric acid, a naturally occurring substance in the body, builds up in the joints and causes sudden attacks of redness, swelling, pain, and heat in one or more joints. Febuxostat is in a class of medications called xanthine oxidase inhibitors. It works by decreasing the amount of uric acid that is made in the body. Febuxostat is used to prevent gout attacks but not to treat them once they occur.
Related Packages: 62332-0191-91Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Febuxostat
Product Information
| NDC | 62332-0191 |
|---|---|
| Product ID | 62332-191_d93f60e8-39b0-4359-9aaa-2e02ac188b1f |
| Associated GPIs | 68000030000330 |
| GCN Sequence Number | 064830 |
| GCN Sequence Number Description | febuxostat TABLET 80 MG ORAL |
| HIC3 | C7A |
| HIC3 Description | HYPERURICEMIA TX - XANTHINE OXIDASE INHIBITORS |
| GCN | 16809 |
| HICL Sequence Number | 036106 |
| HICL Sequence Number Description | FEBUXOSTAT |
| Brand/Generic | Generic |
| Proprietary Name | Febuxostat |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | febuxostat |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, COATED |
| Route | ORAL |
| Active Ingredient Strength | 80 |
| Active Ingredient Units | mg/1 |
| Substance Name | FEBUXOSTAT |
| Labeler Name | Alembic Pharmaceuticals Inc. |
| Pharmaceutical Class | Xanthine Oxidase Inhibitor [EPC], Xanthine Oxidase Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA205421 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 62332-0191-91 (62332019191)
| NDC Package Code | 62332-191-91 |
|---|---|
| Billing NDC | 62332019191 |
| Package | 1000 TABLET, COATED in 1 BOTTLE (62332-191-91) |
| Marketing Start Date | 2019-07-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |