MODEYSO

Orange BookUNIISPL

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerJazz Pharmaceuticals, Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6872725001
1 BOTTLE in 1 CARTON (68727-250-01) / 10 CAPSULE in 1 BOTTLE

Annotations

UNII (FDA Substance ID)

9U35A31JAI

DORDAVIPRONE

Orange Book

N219876

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "9U35A31JAI",
    "rxcui": null,
    "inchikey": "VLULRUCCHYVXOH-UHFFFAOYSA-N",
    "display_name": "DORDAVIPRONE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "ad45b43e-fdef-47ad-9c34-055b41bdc576": {
      "match": "brand_token",
      "title": "MODEYSO (DORDAVIPRONE) CAPSULE [JAZZ PHARMACEUTICALS, INC.]",
      "spl_version": "2",
      "published_date": "2026-01-12"
    }
  },
  "productid": "68727-250_9d57dcc7-fa17-4ecf-ada1-3a4b1cf92032",
  "productndc": "68727-250",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "219876",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 125MG BASE",
        "product_no": "001",
        "approval_date": "Aug 6, 2025"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DORDAVIPRONE",
  "proprietary_name": "MODEYSO",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA219876",
  "marketing_category": "NDA",
  "nonproprietary_name": "dordaviprone",
  "start_marketing_date": "20250806",
  "active_numerator_strength": "125"
}

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