Febuxostat Tablet, Coated
NDC 46708-190

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 46708-190?
  5. Febuxostat Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. NDC to RxNorm Crosswalk
  10. Pharmacologic Classes
  11. Patient Education

Product Information

Febuxostat is a ANDA-approved product labeled by Alembic Pharmaceuticals Limited. Febuxostat is used to lower uric acid levels in people with gout. It is supplied as a green tablet, coated for oral administration. This product entry covers the primary NDC 46708-190 and 5 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
46708-190
Proprietary Name:
Febuxostat
Non-Proprietary Name: [1]
Febuxostat
Substance Name: [2]
Febuxostat
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

Dosage Form:
Tablet, Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is covered with a designated coating.
Administration Route(s): [4]
Oral - Administration to or by way of the mouth.

Labeler & Regulatory Data

Labeler Name: [5]
Alembic Pharmaceuticals Limited
Labeler Code:
46708
Product Label ID:
41a95424-046e-413b-a121-cd7335e67135
FDA Application Number: [6]
ANDA205421
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
07-01-2019
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Product Characteristics

Color(s):
GREEN (C48329 - LIGHT GREEN TO GREEN)
Shape:
ROUND (C48348)
Size(s):
9 MM
Imprint(s):
L440
Score:
1

Code Structure Chart

Product Details

What is NDC 46708-190?

The NDC code 46708-190 is assigned by the FDA to the product Febuxostat. This pharmaceutical product is labeled by Alembic Pharmaceuticals Limited and is currently categorized as listed product. The medication is a tablet, coated administered via oral route. In terms of distribution, this product is available in 5 different package configurations. The associated package NDC(s) include: 46708-190-08, 46708-190-10, 46708-190-30, 46708-190-31, 46708-190-91. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

Febuxostat is used to lower uric acid levels in people with gout. Febuxostat works by reducing the amount of uric acid made by the body. An increased uric acid level can cause gout. Because of the risk of very serious heart-related problems and stroke with febuxostat (see also Warning section), febuxostat should be used only after treatment with a medication called allopurinol did not work to lower your uric acid level, caused serious side effects, or is not recommended by your doctor. Febuxostat should be used only if you have symptoms caused by a high blood uric acid level.

What are Active Ingredients of this product?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • FEBUXOSTAT 40 mg/1 - A thiazole derivative and inhibitor of XANTHINE OXIDASE that is used for the treatment of HYPERURICEMIA in patients with chronic GOUT.

Which are the associated UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are the Inactive Ingredients associated UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for this product?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

Which are the Pharmacologic Classes of this product?

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

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Patient Education

Febuxostat


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.
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* Please review the full disclaimer at the bottom of this page.

Product & Regulatory Definitions
What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
What is the Substance Name? An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
What kind of product is this? Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the FDA Application Number? This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.
What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".