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United States · US · US:13668-542_b3f8fd90-2a0a-46e2-a4d2-e32fbca3aaf2
Macitentan
Orange BookUNIISPLATC C02KX04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerTorrent Pharmaceuticals Limited
CountryUS (United States)
ATC codeC02KX04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc111366854205500 TABLET in 1 BOTTLE (13668-542-05)
- ndc11136685423030 TABLET in 1 BOTTLE (13668-542-30)
- ndc11136685429090 TABLET in 1 BOTTLE (13668-542-90)
Annotations
UNII (FDA Substance ID)
Z9K9Y9WMVL
MACITENTAN
RxCUI 1442132
Orange Book
A211107
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": "13668-542_b3f8fd90-2a0a-46e2-a4d2-e32fbca3aaf2",
"productndc": "13668-542",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "211107",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "001",
"approval_date": "Aug 5, 2024"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "MACITENTAN",
"proprietary_name": "Macitentan",
"active_ingred_unit": "mg/1",
"application_number": "ANDA211107",
"marketing_category": "ANDA",
"nonproprietary_name": "Macitentan",
"start_marketing_date": "20260601",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code C02KX04.
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