Prescription drug · NDA
Modeyso (dordaviprone) NDC 68727-250
Dordaviprone 125 mg/1 · Capsule · Oral · Jazz Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68727-250-01 | 68727025001 | 1 BOTTLE in 1 CARTON (68727-250-01) / 10 CAPSULE in 1 BOTTLEMarketed from Aug 6, 2025 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Modeyso
- Generic name (nonproprietary)
- dordaviprone
- Active ingredients
- Dordaviprone — 125 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Jazz Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 219876
- Marketing start
- Listing expires
- Identifiers
- Product ID 68727-250_9d57dcc7-fa17-4ecf-ada1-3a4b1cf92032SPL ID 9d57dcc7-fa17-4ecf-ada1-3a4b1cf92032SPL set ID ad45b43e-fdef-47ad-9c34-055b41bdc576RxCUI 2721199, 2721205UNII 9U35A31JAI
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N468727025001followed by a unit qualifier and the quantityPackage 68727-0250-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
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). MODEYSO is a protease activator 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 …
Excerpt only. Read the full label for complete information.