Mitosol Kit
NDC Package 49771-002-03

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

Package Information

Mitosol (mitomycin) kits is mitomycin is used to treat various types of cancer (such as stomach/pancreas cancer). This formulation utilizes a kit delivery system. Marketed by Mobius Therapeutics Llc, this product is identified by NDC 49771-002 and is authorized under FDA application NDA022572.

Identification & Billing

NDC Package Code
49771-002-03
Package Description
3 TRAY in 1 CARTON / 1 KIT in 1 TRAY (49771-002-01) * 1 mL in 1 VIAL, SINGLE-USE * 1 mL in 1 SYRINGE, GLASS
Product Code
49771-002
11-Digit Billing Format
49771000203
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Mitosol
Non-Proprietary Name
Mitomycin
Dosage Form
Kit - A packaged collection of related material.
Usage Information
Mitomycin is used to treat various types of cancer (such as stomach/pancreas cancer). It works by slowing or stopping the growth of cancer cells.

Regulatory & Marketing

Labeler Name
Mobius Therapeutics Llc
Product Type
Human Prescription Drug
FDA Application #
NDA022572
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
02-08-2012
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 49771-002-03 identifies a specific commercial package of 3 tray in 1 carton / 1 kit in 1 tray (49771-002-01) * 1 ml in 1 vial, single-use * 1 ml in 1 syringe, glass of Mitosol, a human prescription drug labeled by Mobius Therapeutics Llc. This kit is formulated for use and contains 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 Mobius Therapeutics Llc on February 08, 2012. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Mitomycin is used to treat various types of cancer (such as stomach/pancreas cancer). It works by slowing or stopping the growth of cancer cells.

How is this Mobius Therapeutics Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 49771000203. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. 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)
49771-002-03
11-Digit CMS (5-4-2)
49771-0002-03

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