Imkeldi Solution
NDC Package 81927-201-01

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

Package Information

Imkeldi (imatinib oral) solution is a medication used to treat certain types of cancer (such as acute lymphoblastic leukemia, chronic myeloid leukemia, gastrointestinal stromal tumors, and myelodysplastic/myeloproliferative diseases). This formulation utilizes a solution delivery system. Marketed by Shorla Oncology Inc.,, this product is identified by NDC 81927-201 and is authorized under FDA application NDA219097.

Identification & Billing

NDC Package Code
81927-201-01
Package Description
140 mL in 1 BOTTLE
Product Code
81927-201
11-Digit Billing Format
81927020101
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
140 ML
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Imkeldi
Non-Proprietary Name
Imatinib Oral
Substance Name
Imatinib Mesylate
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
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
IMATINIB MESYLATE 80 mg/mL
Pharmacologic Class
Usage Information
This medication is used to treat certain types of cancer (such as acute lymphoblastic leukemia, chronic myeloid leukemia, gastrointestinal stromal tumors, and myelodysplastic/myeloproliferative diseases). It works by slowing or stopping the growth of cancer cells. Imatinib may also be used to treat certain immune system disorders (such as aggressive systemic mastocytosis, hypereosinophilic syndrome).

Regulatory & Marketing

Labeler Name
Shorla Oncology Inc.,
Product Type
Human Prescription Drug
FDA Application #
NDA219097
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
12-19-2024
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 81927-201-01 identifies a specific commercial package of 140 ml in 1 bottle of Imkeldi, a human prescription drug labeled by Shorla Oncology Inc.,. This product is billed per "ML" milliliter and contains an estimated amount of 140 billable units per package. This solution is formulated for oral use and contains imatinib mesylate 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 Shorla Oncology Inc., on December 19, 2024. 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 (such as acute lymphoblastic leukemia, chronic myeloid leukemia, gastrointestinal stromal tumors, and myelodysplastic/myeloproliferative diseases). It works by slowing or stopping the growth of cancer cells. Imatinib may also be used to treat certain immune system disorders (such as aggressive systemic mastocytosis, hypereosinophilic syndrome).

How is this Shorla Oncology Inc., product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 81927020101. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 140 total billable units per package. 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)
81927-201-01
11-Digit CMS (5-4-2)
81927-0201-01

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