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  4. NDC Product Code: 50090-3418 Methotrexate

NDC 50090-3418 Methotrexate

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 50090-3418?
  5. Methotrexate Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. Patient Education

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Get all the details for National Drug Code (NDC) 50090-3418 in one place. This page breaks down everything you need to know about the NDC, including proprietary name, active and inactive substances, package configurations, billing units, labeler information, and routes of administration. It also includes enhanced data such as HCPCS codes, FDA product labels with images, UNIIs, and RxNorm cross-references. Whether you're a healthcare professional verifying drug data or a consumer researching medication, this NDC page helps you make informed, accurate decisions.

NDC Product Code:
50090-3418
Proprietary Name:
Methotrexate
Product Type: [3]
Labeler Name: [5]
A-s Medication Solutions
Labeler Code:
50090
Product Label ID:
53f9ac10-f012-4290-bc17-b6919cd18323
FDA Application Number: [6]
ANDA201749
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date: [9]
11-10-2017
End Marketing Date: [10]
02-28-2023
Listing Expiration Date: [11]
02-28-2023
Exclude Flag: [12]
D
Code Navigator:

Product Characteristics

Color(s):
YELLOW (C48330)
Shape:
ROUND (C48348)
Size(s):
6 MM
Imprint(s):
ORN57
Score:
2

Code Structure Chart

Product Details

What is NDC 50090-3418?

The NDC code 50090-3418 is assigned by the FDA to the product Methotrexate which is product labeled by A-s Medication Solutions. The product's dosage form is . The product is distributed in 2 packages with assigned NDC codes 50090-3418-2 100 tablet in 1 bottle , 50090-3418-9 36 tablet 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 and RxNorm crosswalk.

What are the uses for Methotrexate?

Methotrexate is used to treat certain types of cancer or to control severe psoriasis or rheumatoid arthritis that has not responded to other treatments. It may also be used to control juvenile rheumatoid arthritis. Methotrexate belongs to a class of drugs known as antimetabolites. It works by slowing or stopping the growth of cancer cells and suppressing the immune system. Early treatment of rheumatoid arthritis with more aggressive therapy such as methotrexate helps to reduce further joint damage and to preserve joint function.

Which are Methotrexate UNII Codes?

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

Which are Methotrexate 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:

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Patient Education

Methotrexate


Methotrexate is used to treat severe psoriasis (a skin disease in which red, scaly patches form on some areas of the body) that cannot be controlled by other treatments. Methotrexate is also used along with rest, physical therapy, and sometimes other medications to treat severe active rheumatoid arthritis (RA; a condition in which the body attacks its own joints, causing pain, swelling, and loss of function) that cannot be controlled by certain other medications. Methotrexate is also used to treat certain types of cancer including cancers that begin in the tissues that form around a fertilized egg in the uterus, breast cancer, lung cancer, certain cancers of the head and neck, certain types of lymphoma, and leukemia (cancer that begins in the white blood cells). Methotrexate is in a class of medications called antimetabolites. Methotrexate treats cancer by slowing the growth of cancer cells. Methotrexate treats psoriasis by slowing the growth of skin cells to stop scales from forming. Methotrexate may treat rheumatoid arthritis by decreasing the activity of the immune system.
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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.

[6] 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.

[8] 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.

[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.

[10] What is the End Marketing Date? - This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

[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, 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".