Modeyso Capsule
NDC Package 68727-250-01

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

Package Information

Modeyso (dordaviprone) capsules is 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)]. This formulation utilizes a capsule delivery system. Marketed by Jazz Pharmaceuticals, Inc., this product is identified by NDC 68727-250 and is authorized under FDA application NDA219876.

Identification & Billing

NDC Package Code
68727-250-01
Package Description
1 BOTTLE in 1 CARTON / 10 CAPSULE in 1 BOTTLE
Product Code
68727-250
11-Digit Billing Format
68727025001
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Modeyso
Non-Proprietary Name
Dordaviprone
Substance Name
Dordaviprone
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
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
DORDAVIPRONE 125 mg/1
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).

Regulatory & Marketing

Labeler Name
Jazz Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA219876
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
08-06-2025
Listing Expiration
12-31-2027
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 68727-250-01 identifies a specific commercial package of 1 bottle in 1 carton / 10 capsule in 1 bottle of Modeyso, a human prescription drug labeled by Jazz Pharmaceuticals, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This capsule is formulated for oral use and contains dordaviprone 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 Jazz Pharmaceuticals, Inc. on August 06, 2025. The current certification is valid through December 31, 2027.

How is this Jazz Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68727025001. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 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)
68727-250-01
11-Digit CMS (5-4-2)
68727-0250-01

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