modeyso

Generic: dordaviprone

Labeler: jazz pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name modeyso
Generic Name dordaviprone
Labeler jazz pharmaceuticals, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

dordaviprone 125 mg/1

Manufacturer
Jazz Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68727-250
Product ID 68727-250_9d57dcc7-fa17-4ecf-ada1-3a4b1cf92032
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA219876
Listing Expiration 2027-12-31
Marketing Start 2025-08-06

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68727250
Hyphenated Format 68727-250

Supplemental Identifiers

RxCUI
2721199 2721205
UNII
9U35A31JAI

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name modeyso (source: ndc)
Generic Name dordaviprone (source: ndc)
Application Number NDA219876 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 125 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (68727-250-01) / 10 CAPSULE in 1 BOTTLE
source: ndc

Packages (1)

68727-250-01 1 BOTTLE in 1 CARTON (68727-250-01) / 10 CAPSULE in 1 BOTTLE

Ingredients (1)

dordaviprone (125 mg/1)

Linked Drug Pages (1)

MODEYSO ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "9d57dcc7-fa17-4ecf-ada1-3a4b1cf92032", "openfda": {"unii": ["9U35A31JAI"], "rxcui": ["2721199", "2721205"], "spl_set_id": ["ad45b43e-fdef-47ad-9c34-055b41bdc576"], "manufacturer_name": ["Jazz Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (68727-250-01)  / 10 CAPSULE in 1 BOTTLE", "package_ndc": "68727-250-01", "marketing_start_date": "20250806"}], "brand_name": "MODEYSO", "product_id": "68727-250_9d57dcc7-fa17-4ecf-ada1-3a4b1cf92032", "dosage_form": "CAPSULE", "product_ndc": "68727-250", "generic_name": "dordaviprone", "labeler_name": "Jazz Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "MODEYSO", "active_ingredients": [{"name": "DORDAVIPRONE", "strength": "125 mg/1"}], "application_number": "NDA219876", "marketing_category": "NDA", "marketing_start_date": "20250806", "listing_expiration_date": "20271231"}