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United States · US · US:70710-1166_a5723ac2-5bfa-4270-9268-6a6533a841f7
MACITENTAN
Orange BookUNIISPLATC C02KX04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerZydus Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeC02KX04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11707101166330 TABLET, FILM COATED in 1 BOTTLE (70710-1166-3)
- ndc1170710116655 BLISTER PACK in 1 CARTON (70710-1166-5) / 3 TABLET, FILM COATED in 1 BLISTER PACK (70710-1166-4)
Annotations
UNII (FDA Substance ID)
Z9K9Y9WMVL
MACITENTAN
RxCUI 1442132
Orange Book
A211224
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": "70710-1166_a5723ac2-5bfa-4270-9268-6a6533a841f7",
"productndc": "70710-1166",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "211224",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "001",
"approval_date": "Apr 6, 2021"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "MACITENTAN",
"proprietary_name": "MACITENTAN",
"active_ingred_unit": "mg/1",
"application_number": "ANDA211224",
"marketing_category": "ANDA",
"nonproprietary_name": "MACITENTAN",
"start_marketing_date": "20251105",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code C02KX04.
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