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United States · US · US:25682-043_cd0113b0-d5d6-4b03-9f6f-4d80bdcb71fe
Voydeya
Orange BookUNIISPLATC L04AJ09
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAlexion Pharmaceuticals Inc.
CountryUS (United States)
ATC codeL04AJ09
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1125682043922 BOTTLE in 1 CARTON (25682-043-92) / 90 TABLET, FILM COATED in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
JM8C1SFX0U
DANICOPAN
Orange Book
N218037
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "JM8C1SFX0U",
"rxcui": null,
"inchikey": "PIBARDGJJAGJAJ-NQIIRXRSSA-N",
"display_name": "DANICOPAN",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"ab8d1cbd-a28b-4d49-82ab-5c7460719ac7": {
"match": "brand_token",
"title": "VOYDEYA (DANICOPAN) TABLET, FILM COATED VOYDEYA (DANICOPAN) KIT [ALEXION PHARMACEUTICALS INC.]",
"spl_version": "5",
"published_date": "2026-05-20"
}
},
"productid": "25682-043_cd0113b0-d5d6-4b03-9f6f-4d80bdcb71fe",
"productndc": "25682-043",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "218037",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "50MG",
"product_no": "001",
"approval_date": "Mar 29, 2024"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "100MG",
"product_no": "002",
"approval_date": "Mar 29, 2024"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DANICOPAN",
"proprietary_name": "Voydeya",
"active_ingred_unit": "mg/1",
"application_number": "NDA218037",
"marketing_category": "NDA",
"nonproprietary_name": "Danicopan",
"start_marketing_date": "20240329",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code L04AJ09.
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