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United States · US · US:0591-2511_8f3d0f83-84b4-4860-9478-c86488f41001
bosentan
In shortageOrange BookUNIISPLATC C02KX01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerActavis Pharma, Inc.
CountryUS (United States)
ATC codeC02KX01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11059125116060 TABLET, FILM COATED in 1 BOTTLE (0591-2511-60)
Annotations
UNII (FDA Substance ID)
Q326023R30
BOSENTAN
RxCUI 75207
Orange Book
A207110
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": "0591-2511_8f3d0f83-84b4-4860-9478-c86488f41001",
"productndc": "0591-2511",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "207110",
"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": "ANDA207110",
"marketing_category": "ANDA",
"nonproprietary_name": "bosentan",
"start_marketing_date": "20190619",
"active_numerator_strength": "62.5"
}Related drugs
Other records sharing ATC code C02KX01.
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