Methotrexate Solution
NDC Package 0143-9518-01

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

Package Information

Methotrexate solution is methotrexate is used to treat certain types of cancer or to control severe psoriasis or rheumatoid arthritis that has not responded to other treatments. This formulation utilizes a solution delivery system. Marketed by Hikma Pharmaceuticals Usa Inc., this product is identified by NDC 0143-9518 and is authorized under FDA application ANDA089341.

Identification & Billing

NDC Package Code
0143-9518-01
Package Description
1 VIAL in 1 BOX / 4 mL in 1 VIAL
Product Code
0143-9518
11-Digit Billing Format
00143951801
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Methotrexate
Non-Proprietary Name
Methotrexate
Substance Name
Methotrexate
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
  • Intra-arterial - Administration within an artery or arteries.
  • Intramuscular - Administration within a muscle.
  • Intrathecal - Administration within the cerebrospinal fluid at any level of the cerebrospinal axis, including injection into the cerebral ventricles.
  • Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
METHOTREXATE 25 mg/mL
Pharmacologic Class
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
Hikma Pharmaceuticals Usa Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA089341
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-05-2018
Listing Expiration
12-31-2026
Exclude Flag
N
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 0143-9518-01 identifies a specific commercial package of 1 vial in 1 box / 4 ml in 1 vial of Methotrexate, a human prescription drug labeled by Hikma Pharmaceuticals Usa Inc.. This solution is formulated for intra-arterial; intramuscular; intrathecal; intravenous use and contains methotrexate as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Hikma Pharmaceuticals Usa Inc. on January 05, 2018. The current certification is valid through December 31, 2026.

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 Hikma Pharmaceuticals Usa Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00143951801. 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 (4-4-2)
0143-9518-01
11-Digit CMS (5-4-2)
00143-9518-01

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