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NDC 00378-3925-93 Febuxostat 40 mg/1 Details
Febuxostat 40 mg/1
Febuxostat is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Mylan 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: 00378-3925-93Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Febuxostat
Product Information
| NDC | 00378-3925 |
|---|---|
| Product ID | 0378-3925_3f5600cd-1f2f-410a-8c55-b8363d4fc492 |
| Associated GPIs | 68000030000320 |
| GCN Sequence Number | 064829 |
| GCN Sequence Number Description | febuxostat TABLET 40 MG ORAL |
| HIC3 | C7A |
| HIC3 Description | HYPERURICEMIA TX - XANTHINE OXIDASE INHIBITORS |
| GCN | 16808 |
| 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, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 40 |
| Active Ingredient Units | mg/1 |
| Substance Name | FEBUXOSTAT |
| Labeler Name | Mylan Pharmaceuticals Inc. |
| Pharmaceutical Class | Xanthine Oxidase Inhibitor [EPC], Xanthine Oxidase Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA205385 |
| Listing Certified Through | 2023-12-31 |
Package
NDC 00378-3925-93 (00378392593)
| NDC Package Code | 0378-3925-93 |
|---|---|
| Billing NDC | 00378392593 |
| Package | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3925-93) |
| Marketing Start Date | 2019-07-01 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.63243 |
| Pricing Unit | EA |
| Effective Date | 2022-11-23 |
| NDC Description | FEBUXOSTAT 40 MG TABLET |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 1 |
| Classification for Rate Setting | G |
| As of Date | 2022-11-23 |