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United States · US · US:70771-1018_33935d05-c8ff-4d9e-91bf-fac9072d25fd
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 · 5
- ndc117077110181100 TABLET in 1 BOTTLE (70771-1018-1)
- ndc11707711018410 BLISTER PACK in 1 CARTON (70771-1018-4) / 10 TABLET in 1 BLISTER PACK (70771-1018-2)
- ndc117077110185500 TABLET in 1 BOTTLE (70771-1018-5)
- ndc11707711018660 TABLET in 1 BOTTLE (70771-1018-6)
- ndc117077110188180 TABLET in 1 BOTTLE (70771-1018-8)
Annotations
UNII (FDA Substance ID)
Q326023R30
BOSENTAN
RxCUI 75207
Orange Book
A207760
ABAB
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": "70771-1018_33935d05-c8ff-4d9e-91bf-fac9072d25fd",
"productndc": "70771-1018",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "207760",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "62.5MG",
"product_no": "001",
"approval_date": "Apr 26, 2019"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "125MG",
"product_no": "002",
"approval_date": "Apr 26, 2019"
}
],
"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": "ANDA207760",
"marketing_category": "ANDA",
"nonproprietary_name": "Bosentan",
"start_marketing_date": "20190501",
"active_numerator_strength": "125"
}Related drugs
Other records sharing ATC code C02KX01.
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