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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
- ndc1127505111141 BLISTER PACK in 1 CARTON (27505-111-14) / 14 TABLET, FILM COATED in 1 BLISTER PACK
- ndc1127505111301 BOTTLE in 1 CARTON (27505-111-30) / 30 TABLET, FILM COATED in 1 BOTTLE
- ndc1127505111901 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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