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United States · US · US:66215-501_3282790e-e454-3214-e063-6294a90a526b
OPSUMIT
Orange BookUNIISPLATC C02KX04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerActelion Pharmaceuticals US, Inc.
CountryUS (United States)
ATC codeC02KX04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1166215501151 BLISTER PACK in 1 CARTON (66215-501-15) / 15 TABLET, FILM COATED in 1 BLISTER PACK
- ndc1166215501301 BOTTLE in 1 CARTON (66215-501-30) / 30 TABLET, FILM COATED in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
Z9K9Y9WMVL
MACITENTAN
RxCUI 1442132
Orange Book
N204410
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "Z9K9Y9WMVL",
"rxcui": "1442132",
"inchikey": "JGCMEBMXRHSZKX-UHFFFAOYSA-N",
"display_name": "MACITENTAN",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"1e484a50-55db-4b85-8c57-6cd1b0353abd": {
"match": "brand_token",
"title": "OPSUMIT (MACITENTAN) TABLET, FILM COATED [ACTELION PHARMACEUTICALS US, INC.]",
"spl_version": "35",
"published_date": "2025-04-14"
}
},
"productid": "66215-501_3282790e-e454-3214-e063-6294a90a526b",
"productndc": "66215-501",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "204410",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "10MG",
"product_no": "001",
"approval_date": "Oct 18, 2013"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "MACITENTAN",
"proprietary_name": "OPSUMIT",
"active_ingred_unit": "mg/1",
"application_number": "NDA204410",
"marketing_category": "NDA",
"nonproprietary_name": "macitentan",
"start_marketing_date": "20131104",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code C02KX04.
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