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  5. NDC Package Code: 68727-250-01 Modeyso

NDC Package 68727-250-01 Modeyso

Dordaviprone Capsule 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:
68727-250-01
Package Description:
1 BOTTLE in 1 CARTON / 10 CAPSULE in 1 BOTTLE
Product Code:
68727-250
Proprietary Name:
Modeyso
Non-Proprietary Name:
Dordaviprone
Substance Name:
Dordaviprone
Usage Information:
MODEYSO is indicated for the treatment of adult and pediatric patients 1 year of age and older with diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy.This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
11-Digit NDC Billing Format:
68727025001
Product Type:
Human Prescription Drug
Labeler Name:
Jazz Pharmaceuticals, Inc.
Dosage Form:
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route(s):
Oral - Administration to or by way of the mouth.
Active Ingredient(s):
DORDAVIPRONE 125 mg/1
Sample Package:
No
FDA Application Number:
NDA219876
Marketing Category:
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date:
08-06-2025
Listing Expiration Date:
12-31-2026
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 68727-250-01?

The NDC Packaged Code 68727-250-01 is assigned to a package of 1 bottle in 1 carton / 10 capsule in 1 bottle of Modeyso, a human prescription drug labeled by Jazz Pharmaceuticals, Inc.. The product's dosage form is capsule and is administered via oral form.

Is NDC 68727-250 included in the NDC Directory?

Yes, Modeyso with product code 68727-250 is active and included in the NDC Directory. The product was first marketed by Jazz Pharmaceuticals, Inc. on August 06, 2025 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 68727-250-01?

The 11-digit format is 68727025001. 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
5-3-268727-250-015-4-268727-0250-01