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United States · US · US:70771-1908_008fc213-caa0-4d52-9ee2-e3628c19b90b
bosentan
In shortageOrange BookUNIISPLATC C02KX01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerZydus Lifesciences Limited
CountryUS (United States)
ATC codeC02KX01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1170771190884 BLISTER PACK in 1 CARTON (70771-1908-8) / 14 TABLET, FOR SUSPENSION in 1 BLISTER PACK (70771-1908-7)
Annotations
UNII (FDA Substance ID)
Q326023R30
BOSENTAN
RxCUI 75207
Orange Book
A213981
AB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Bosentan Tablet
Raw payload (JSON)
{
"unii": {
"unii": "Q326023R30",
"rxcui": "75207",
"inchikey": "SXTRWVVIEPWAKM-UHFFFAOYSA-N",
"display_name": "BOSENTAN",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"b88cc559-93ae-42db-9c38-fb5e9c4802e6": {
"match": "brand_token",
"title": "BOSENTAN TABLET, FOR SUSPENSION [ZYDUS LIFESCIENCES LIMITED]",
"spl_version": "1",
"published_date": "2026-02-18"
}
},
"productid": "70771-1908_008fc213-caa0-4d52-9ee2-e3628c19b90b",
"productndc": "70771-1908",
"dosage_form": "TABLET, FOR SUSPENSION",
"orange_book": {
"appl_no": "213981",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "32MG",
"product_no": "001",
"approval_date": "Feb 17, 2026"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BOSENTAN",
"shortage_reason": "Bosentan Tablet",
"shortage_status": "current",
"proprietary_name": "bosentan",
"active_ingred_unit": "mg/1",
"application_number": "ANDA213981",
"marketing_category": "ANDA",
"nonproprietary_name": "bosentan",
"start_marketing_date": "20260217",
"active_numerator_strength": "32"
}Related drugs
Other records sharing ATC code C02KX01.
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