Otrexup
NDC Package 54436-075-01

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

Package Information

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

Otrexup is methotrexate is used to control severe psoriasis or rheumatoid arthritis that has not responded to other treatments. Marketed by Antares Pharma, Inc., this product is identified by NDC 54436-075 and is authorized under FDA application NDA204824.

Identification & Billing

NDC Package Code
54436-075-01
Package Description
1 SYRINGE in 1 CARTON / .4 mL in 1 SYRINGE
Product Code
54436-075
11-Digit Billing Format
54436007501
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Otrexup
Dosage Form
-
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.

Regulatory & Marketing

Labeler Name
Antares Pharma, Inc.
FDA Application #
NDA204824
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
10-11-2013
End Marketing Date
09-30-2016
Listing Expiration
09-30-2016
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (54436-075). Click a package code to view its specific billing and regulatory data.

54436-075-04
4 SYRINGE in 1 CARTON / .4 mL in 1 SYRINGE (54436-075-02)

* 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 54436-075-01 identifies a specific commercial package of 1 syringe in 1 carton / .4 ml in 1 syringe of Otrexup, labeled by Antares Pharma, Inc.. 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 Antares Pharma, Inc. on October 11, 2013. The current certification is valid through September 30, 2016.

What are the primary indications for this medication?

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.

How is this Antares Pharma, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54436007501. 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)
54436-075-01
11-Digit CMS (5-4-2)
54436-0075-01

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