NDC 31722-247 Teriflunomide
Tablet, Film Coated Oral

Product Information

What is NDC 31722-247?

The NDC code 31722-247 is assigned by the FDA to the product Teriflunomide which is a human prescription drug product labeled by Camber Pharmaceuticals, Inc.. The product's dosage form is tablet, film coated and is administered via oral form. The product is distributed in a single package with assigned NDC code 31722-247-30 30 tablet, film coated in 1 bottle . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code	31722-247
Proprietary Name What is the Proprietary Name? The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.	Teriflunomide
Non-Proprietary Name 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.	Teriflunomide
Product Type 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.	Human Prescription Drug
Dosage Form	Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route(s) What are the Administration Route(s)? The translation of the route code submitted by the firm, indicating route of administration.	Oral - Administration to or by way of the mouth.
Product Labeler Information What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.	Camber Pharmaceuticals, Inc.
Labeler Code	31722
FDA Application Number 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.	ANDA209598
Marketing Category 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.	ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.	03-13-2023
Listing Expiration Date 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.	12-31-2024
Exclude Flag 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".	N
NDC Code Structure	31722 - Camber Pharmaceuticals, Inc. 31722-247 - Teriflunomide 31722-247-30

What are the uses for Teriflunomide?

This medication is used to treat multiple sclerosis-MS. It is not a cure for MS but is thought to work by decreasing certain immune system cells (lymphocytes) which can attack the nerves in your brain and spinal cord. This helps decrease the number of flare-ups (relapses) and may help slow down physical problems caused by MS.

Product Packages

NDC Code 31722-247-30

Package Description: 30 TABLET, FILM COATED in 1 BOTTLE

Product Details

What are Teriflunomide Active Ingredients?

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.

TERIFLUNOMIDE 14 mg/1

Pharmacologic Class(es)

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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