🇺🇸
United States · US · US:42385-907_93f0ab4a-4756-4915-a000-ed65b26cd61c
Macitentan
Orange BookUNIISPLATC C02KX04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerLaurus Labs Limited
CountryUS (United States)
ATC codeC02KX04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1142385907151 BLISTER PACK in 1 CARTON (42385-907-15) / 15 TABLET, FILM COATED in 1 BLISTER PACK
- ndc11423859073030 TABLET, FILM COATED in 1 BOTTLE (42385-907-30)
Annotations
UNII (FDA Substance ID)
Z9K9Y9WMVL
MACITENTAN
RxCUI 1442132
Orange Book
A211120
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": {
"fbfae088-44e6-4296-81d1-c2b6eecacc81": {
"match": "brand_token",
"title": "MACITENTAN TABLET [TORRENT PHARMACEUTICALS LIMITED]",
"spl_version": "7",
"published_date": "2026-06-02"
}
},
"productid": "42385-907_93f0ab4a-4756-4915-a000-ed65b26cd61c",
"productndc": "42385-907",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "211120",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "001",
"approval_date": "Nov 5, 2025"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "MACITENTAN",
"proprietary_name": "Macitentan",
"active_ingred_unit": "mg/1",
"application_number": "ANDA211120",
"marketing_category": "ANDA",
"nonproprietary_name": "Macitentan",
"start_marketing_date": "20260515",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code C02KX04.
Access this data programmatically
Query Macitentan and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.