Dasatinib Monolauryl Sulfate Powder, For Suspension
NDC Package 61200-106-02

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 an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Dasatinib Monolauryl Sulfate powders is a medication used to treat certain types of cancer (chronic myeloid leukemia-CML, acute lymphoblastic leukemia-ALL). This formulation utilizes a powder, for suspension delivery system. Marketed by Sichuan Xieli Pharmaceutical Co., Ltd., this product is identified by NDC 61200-106.

Identification & Billing

NDC Package Code
61200-106-02
Package Description
.2 kg in 1 PACKAGE
Product Code
61200-106
11-Digit Billing Format
61200010602

Clinical Specifications

Proprietary Name
Dasatinib Monolauryl Sulfate
Non-Proprietary Name
Dasatinib Monolauryl Sulfate
Substance Name
Dasatinib
Dosage Form
Powder, For Suspension - An intimate mixture of dry, finely divided drugs and/or chemicals, which, upon the addition of suitable vehicles, yields a suspension (a liquid preparation containing the solid particles dispersed in the liquid vehicle).
Active Ingredient(s)
DASATINIB 1 kg/kg
Usage Information
This medication is used to treat certain types of cancer (chronic myeloid leukemia-CML, acute lymphoblastic leukemia-ALL). It works by slowing or stopping the growth of cancer cells.

Regulatory & Marketing

Labeler Name
Sichuan Xieli Pharmaceutical Co., Ltd.
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING - A category specifying that a bulk product is intended for use on humans and requires a prescription.
Start Marketing Date
12-19-2019
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 61200-106-02 identifies a specific commercial package of .2 kg in 1 package of Dasatinib Monolauryl Sulfate (UNFINISHED drug), a bulk ingredient labeled by Sichuan Xieli Pharmaceutical Co., Ltd.. This powder, for suspension is formulated for use and contains dasatinib 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 Sichuan Xieli Pharmaceutical Co., Ltd. on December 19, 2019. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat certain types of cancer (chronic myeloid leukemia-CML, acute lymphoblastic leukemia-ALL). It works by slowing or stopping the growth of cancer cells.

How is this Sichuan Xieli Pharmaceutical Co., Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 61200010602. 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)
61200-106-02
11-Digit CMS (5-4-2)
61200-0106-02

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