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United States · US · US:27505-111_41c1c50d-7460-15f0-e063-6294a90a1b79

Xadago

Orange BookUNIISPLATC N04BD03

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerMDD US Operations LLC, a subsidiary of Supernus Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeN04BD03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    2750511114
    1 BLISTER PACK in 1 CARTON (27505-111-14) / 14 TABLET, FILM COATED in 1 BLISTER PACK
  • ndc11
    2750511130
    1 BOTTLE in 1 CARTON (27505-111-30) / 30 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    2750511190
    1 BOTTLE in 1 CARTON (27505-111-90) / 90 TABLET, FILM COATED in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
YS90V3DTX0
SAFINAMIDE MESYLATE
RxCUI 1922449
Orange Book
N207145
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "YS90V3DTX0",
    "rxcui": "1922449",
    "inchikey": "YKOCHIUQOBQIAC-YDALLXLXSA-N",
    "display_name": "SAFINAMIDE MESYLATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "c4d65f28-983f-42b4-bb23-023ae0fe81b2": {
      "match": "brand_token",
      "title": "XADAGO (SAFINAMIDE MESYLATE) TABLET, FILM COATED [MDD US OPERATIONS LLC, A SUBSIDIARY OF SUPERNUS PHARMACEUTICALS, INC.]",
      "spl_version": "20",
      "published_date": "2025-11-17"
    }
  },
  "productid": "27505-111_41c1c50d-7460-15f0-e063-6294a90a1b79",
  "productndc": "27505-111",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "207145",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 50MG BASE",
        "product_no": "001",
        "approval_date": "Mar 21, 2017"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 100MG BASE",
        "product_no": "002",
        "approval_date": "Mar 21, 2017"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SAFINAMIDE MESYLATE",
  "proprietary_name": "Xadago",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA207145",
  "marketing_category": "NDA",
  "nonproprietary_name": "safinamide mesylate",
  "start_marketing_date": "20170508",
  "active_numerator_strength": "100"
}

Related drugs

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