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  5. NDC Package Code: 81927-201-01 Imkeldi

NDC Package 81927-201-01 Imkeldi

Imatinib Oral Solution Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
81927-201-01
Package Description:
140 mL in 1 BOTTLE
Product Code:
81927-201
Proprietary Name:
Imkeldi
Non-Proprietary Name:
Imatinib Oral
Substance Name:
Imatinib Mesylate
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).
11-Digit NDC Billing Format:
81927020101
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
140 ML
NDC to RxNorm Crosswalk:
Product Type:
Human Prescription Drug
Labeler Name:
Shorla Oncology Inc.,
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(s):
Oral - Administration to or by way of the mouth.
Active Ingredient(s):
IMATINIB MESYLATE 80 mg/mL
Pharmacologic Class(es):
Sample Package:
No
FDA Application Number:
NDA219097
Marketing Category:
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date:
12-19-2024
Listing Expiration Date:
12-31-2025
Exclude Flag:
N
Code Structure:

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 disclaimer below.

Frequently Asked Questions

What is NDC 81927-201-01?

The NDC Packaged Code 81927-201-01 is assigned to a package of 140 ml in 1 bottle of Imkeldi, a human prescription drug labeled by Shorla Oncology Inc.,. The product's dosage form is solution and is administered via oral form.This product is billed per "ML" milliliter and contains an estimated amount of 140 billable units per package.

Is NDC 81927-201 included in the NDC Directory?

Yes, Imkeldi with product code 81927-201 is active and included in the NDC Directory. The product was first marketed by Shorla Oncology Inc., on December 19, 2024 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 81927-201-01?

The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume. The calculated billable units for this package is 140.

What is the 11-digit format for NDC 81927-201-01?

The 11-digit format is 81927020101. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
5-3-281927-201-015-4-281927-0201-01