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  5. NDC Package Code: 54436-015-04 Otrexup

NDC Package 54436-015-04 Otrexup

Methotrexate Injection, Solution Subcutaneous - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. 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:
54436-015-04
Package Description:
4 SYRINGE in 1 CARTON / .4 mL in 1 SYRINGE (54436-015-02)
Product Code:
54436-015
Proprietary Name:
Otrexup
Non-Proprietary Name:
Methotrexate
Substance Name:
Methotrexate
Usage Information:
Methotrexate is used 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 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:
54436001504
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 1441402 - methotrexate 10 MG in 0.4 ML Auto-Injector
  • RxCUI: 1441402 - 0.4 ML methotrexate 25 MG/ML Auto-Injector
  • RxCUI: 1441402 - methotrexate 10 MG per 0.4 ML Auto-Injector
  • RxCUI: 1441407 - Otrexup 10 MG in 0.4 ML Auto-Injector
  • RxCUI: 1441407 - 0.4 ML methotrexate 25 MG/ML Auto-Injector [Otrexup]
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Antares Pharma, Inc.
    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):
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
    • Active Ingredient(s):
  • METHOTREXATE 15 mg/.4mL
    • Pharmacologic Class(es):
  • Folate Analog Metabolic Inhibitor - [EPC] (Established Pharmacologic Class)
  • Folic Acid Metabolism Inhibitors - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    NDA204824
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    10-11-2013
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 CodePackage Description
    54436-015-011 SYRINGE in 1 CARTON / .4 mL in 1 SYRINGE
    54436-015-031 SYRINGE in 1 CARTON / .4 mL in 1 SYRINGE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 54436-015-04?

    The NDC Packaged Code 54436-015-04 is assigned to a package of 4 syringe in 1 carton / .4 ml in 1 syringe (54436-015-02) of Otrexup, a human prescription drug labeled by Antares Pharma, Inc.. The product's dosage form is injection, solution and is administered via subcutaneous form.

    Is NDC 54436-015 included in the NDC Directory?

    Yes, Otrexup with product code 54436-015 is active and included in the NDC Directory. The product was first marketed by Antares Pharma, Inc. on October 11, 2013 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 54436-015-04?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 54436-015-04?

    The 11-digit format is 54436001504. 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 Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-254436-015-045-4-254436-0015-04