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United States · US · US:68382-446_f6180792-cb7a-46ef-b2bb-4a819e4901bb
Bosentan
In shortageOrange BookUNIISPLATC C02KX01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerZydus Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeC02KX01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc116838244601100 TABLET, COATED in 1 BOTTLE (68382-446-01)
- ndc116838244605500 TABLET, COATED in 1 BOTTLE (68382-446-05)
- ndc11683824461460 TABLET, COATED in 1 BOTTLE (68382-446-14)
- ndc116838244628180 TABLET, COATED in 1 BOTTLE (68382-446-28)
- ndc11683824467710 BLISTER PACK in 1 CARTON (68382-446-77) / 10 TABLET, COATED in 1 BLISTER PACK (68382-446-30)
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": "68382-446_f6180792-cb7a-46ef-b2bb-4a819e4901bb",
"productndc": "68382-446",
"dosage_form": "TABLET, COATED",
"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": "62.5"
}Related drugs
Other records sharing ATC code C02KX01.
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