NDC Package 55150-512-01 Methotrexate

Injection, Solution Intramuscular; Intrathecal; Intravenous; Subcutaneous - View Billable Units, 11-Digit Format, RxNorm

Package Information
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Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:

55150-512-01

Package Description:

1 VIAL, SINGLE-DOSE in 1 CARTON / 8 mL in 1 VIAL, SINGLE-DOSE

Product Code:

55150-512

Proprietary Name:

Methotrexate

Non-Proprietary Name:

Methotrexate

Substance Name:

Methotrexate Sodium

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.

11-Digit NDC Billing Format:

55150051201

NDC to RxNorm Crosswalk:

RxCUI: 1655959 - methotrexate 250 MG in 10 ML Injection
RxCUI: 1655959 - 10 ML methotrexate 25 MG/ML Injection
RxCUI: 1655959 - methotrexate 250 MG per 10 ML Injection
RxCUI: 1655960 - methotrexate 50 MG in 2 ML Injection
RxCUI: 1655960 - 2 ML methotrexate 25 MG/ML Injection

Product Type:

Human Prescription Drug

Labeler Name:

Eugia Us Llc

Dosage Form:

Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.

Administration Route(s):

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.
Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.

Active Ingredient(s):

METHOTREXATE SODIUM 200 mg/8mL

Pharmacologic Class(es):

Sample Package:

FDA Application Number:

ANDA201529

Marketing Category:

ANDA - A product marketed under an approved Abbreviated New Drug Application.

Start Marketing Date:

09-11-2024

Listing Expiration Date:

12-31-2026

Exclude Flag:

Code Structure:

55150 - Eugia Us Llc
- 55150-512 - Methotrexate
  - 55150-512-01 - 1 VIAL, SINGLE-DOSE in 1 CARTON / 8 mL in 1 VIAL, SINGLE-DOSE

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 disclaimer below.

Other Product Packages

The following packages are also available for this product:

NDC Package Code	Package Description
55150-512-10	10 VIAL, SINGLE-DOSE in 1 CARTON / 8 mL in 1 VIAL, SINGLE-DOSE

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 55150-512-01?

The NDC Packaged Code 55150-512-01 is assigned to a package of 1 vial, single-dose in 1 carton / 8 ml in 1 vial, single-dose of Methotrexate, a human prescription drug labeled by Eugia Us Llc. The product's dosage form is injection, solution and is administered via intramuscular; intrathecal; intravenous; subcutaneous form.

Is NDC 55150-512 included in the NDC Directory?

Yes, Methotrexate with product code 55150-512 is active and included in the NDC Directory. The product was first marketed by Eugia Us Llc on September 11, 2024 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 55150-512-01?

The 11-digit format is 55150051201. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-3-2	55150-512-01	5-4-2	55150-0512-01

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