Methotrexate
NDC Package 55390-034-10

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

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

Methotrexate is used to treat certain types of cancer or to control severe psoriasis or rheumatoid arthritis that has not responded to other treatments. Marketed by Bedford Laboratories, this product is identified by NDC 55390-034 and is authorized under FDA application ANDA089343.

Identification & Billing

NDC Package Code
55390-034-10
Package Description
10 VIAL in 1 BOX, UNIT-DOSE / 10 mL in 1 VIAL
Product Code
55390-034
11-Digit Billing Format
55390003410
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

Clinical Specifications

Proprietary Name
Methotrexate
Dosage Form
-
Usage Information
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.

Regulatory & Marketing

Labeler Name
Bedford Laboratories
FDA Application #
ANDA089343
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-01-1996
End Marketing Date
10-31-2012
Listing Expiration
10-31-2012
Exclude Flag
D
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

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

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 55390-034-10 identifies a specific commercial package of 10 vial in 1 box, unit-dose / 10 ml in 1 vial of Methotrexate, labeled by Bedford Laboratories. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Bedford Laboratories on May 01, 1996. The current certification is valid through October 31, 2012.

What are the primary indications for this medication?

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.

How is this Bedford Laboratories product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 55390003410. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
55390-034-10
11-Digit CMS (5-4-2)
55390-0034-10

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.