Mesna Solution
NDC Package 68083-161-01

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

Mesna (mesna injection) solution 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. This formulation utilizes a solution delivery system. Marketed by Gland Pharma Limited, this product is identified by NDC 68083-161 and is authorized under FDA application ANDA206992.

Identification & Billing

NDC Package Code
68083-161-01
Package Description
1 VIAL, MULTI-DOSE in 1 CARTON / 10 mL in 1 VIAL, MULTI-DOSE
Product Code
68083-161
11-Digit Billing Format
68083016101
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Mesna
Non-Proprietary Name
Mesna Injection
Substance Name
Mesna
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
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
MESNA 100 mg/mL
Pharmacologic Class
Cytoprotective Agent - [EPC] (Established Pharmacologic Class)
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
Gland Pharma Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA206992
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-20-2017
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (68083-161). Click a package code to view its specific billing and regulatory data.

68083-161-10
10 VIAL, MULTI-DOSE in 1 CARTON / 10 mL in 1 VIAL, MULTI-DOSE

* 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 68083-161-01 identifies a specific commercial package of 1 vial, multi-dose in 1 carton / 10 ml in 1 vial, multi-dose of Mesna, a human prescription drug labeled by Gland Pharma Limited. This solution is formulated for intravenous use and contains mesna 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 Gland Pharma Limited on December 20, 2017. The current certification is valid through December 31, 2026.

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 Gland Pharma Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68083016101. 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)
68083-161-01
11-Digit CMS (5-4-2)
68083-0161-01

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