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  4. NDC Product Code: 0115-1565 Teriflunomide

NDC 0115-1565 Teriflunomide

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 0115-1565?
  5. Teriflunomide Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Patient Education

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
0115-1565
Proprietary Name:
Teriflunomide
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Amneal Pharmaceuticals Of New York Llc
Labeler Code:
0115
Product Label ID:
57a0226d-74a3-4753-8683-ddc86dade0ae
Start Marketing Date: [9]
06-17-2020
Listing Expiration Date: [11]
12-31-2022
Exclude Flag: [12]
I
Code Navigator:

Product Characteristics

Color(s):
BLUE (C48333 - PALE BLUE TO PASTEL BLUE)
Shape:
ROUND (C48348)
Size(s):
7 MM
Imprint(s):
14
Score:
1

Code Structure Chart

Product Details

What is NDC 0115-1565?

The NDC code 0115-1565 is assigned by the FDA to the product Teriflunomide which is product labeled by Amneal Pharmaceuticals Of New York Llc. The product's dosage form is . The product is distributed in a single package with assigned NDC code 0115-1565-44 28 tablet, film coated in 1 carton . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Teriflunomide?

Teriflunomide tablets are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

Which are Teriflunomide UNII Codes?

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

Which are Teriflunomide Inactive Ingredients 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 Teriflunomide?

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 code indicates a single concept unique identifier (RXCUI) is associated with this product:

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Patient Education

Teriflunomide


Teriflunomide is used to treat adults with various forms of multiple sclerosis (MS; a disease in which the nerves do not function properly and people may experience weakness, numbness, loss of muscle coordination, and problems with vision, speech, and bladder control) including: clinically isolated syndrome (CIS; nerve symptom episodes that last at least 24 hours), relapsing-remitting forms (course of disease where symptoms flare up from time to time), or secondary progressive forms (course of disease where relapses occur more often). Teriflunomide is in a class of medications called immunomodulatory agents. It is thought to work by decreasing inflammation and decreasing the action of immune cells that may cause nerve damage.
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Product Footnotes

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] 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] 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".