Mesna
NDC Package 76126-075-01

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.

Mesna is a medication used to reduce the risk of bleeding in the bladder (hemorrhagic cystitis), which is a very serious side effect of treatment with a cancer chemotherapy drug called ifosfamide. Marketed by Agila Specialties Private Limited, this product is identified by NDC 76126-075 and is authorized under FDA application ANDA203364.

Identification & Billing

NDC Package Code
76126-075-01
Package Description
1 VIAL, MULTI-DOSE in 1 CARTON / 10 mL in 1 VIAL, MULTI-DOSE
Product Code
76126-075
11-Digit Billing Format
76126007501

Clinical Specifications

Proprietary Name
Mesna
Dosage Form
-
Usage Information
This medication is used to reduce the risk of bleeding in the bladder (hemorrhagic cystitis), which is a very serious side effect of treatment with a cancer chemotherapy drug called ifosfamide. Mesna helps to protect the lining of the bladder against damage from ifosfamide. The body breaks down ifosfamide to form a product that can harm the bladder, and mesna works by making this product less harmful. However, mesna does not change ifosfamide's anti-cancer effects.

Regulatory & Marketing

Labeler Name
Agila Specialties Private Limited
FDA Application #
ANDA203364
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-19-2014
End Marketing Date
09-01-2017
Listing Expiration
09-01-2017
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 76126-075-01 identifies a specific commercial package of 1 vial, multi-dose in 1 carton / 10 ml in 1 vial, multi-dose of Mesna, labeled by Agila Specialties Private Limited. 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 Agila Specialties Private Limited on July 19, 2014. The current certification is valid through September 01, 2017.

What are the primary indications for this medication?

This medication is used to reduce the risk of bleeding in the bladder (hemorrhagic cystitis), which is a very serious side effect of treatment with a cancer chemotherapy drug called ifosfamide. Mesna helps to protect the lining of the bladder against damage from ifosfamide. The body breaks down ifosfamide to form a product that can harm the bladder, and mesna works by making this product less harmful. However, mesna does not change ifosfamide's anti-cancer effects.

How is this Agila Specialties Private Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76126007501. 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)
76126-075-01
11-Digit CMS (5-4-2)
76126-0075-01

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