🇺🇸
United States · US · US:68180-340_063d2028-f666-4304-8cd3-21d882d8c97f
Bosentan
In shortageOrange BookUNIISPLATC C02KX01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerLupin Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeC02KX01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1168180340134 BLISTER PACK in 1 CARTON (68180-340-13) / 14 TABLET, FOR SUSPENSION in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
Q326023R30
BOSENTAN
RxCUI 75207
Orange Book
A213154
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": "68180-340_063d2028-f666-4304-8cd3-21d882d8c97f",
"productndc": "68180-340",
"dosage_form": "TABLET, FOR SUSPENSION",
"orange_book": {
"appl_no": "213154",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "32MG",
"product_no": "001",
"approval_date": "Feb 5, 2025"
}
],
"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": "ANDA213154",
"marketing_category": "ANDA",
"nonproprietary_name": "Bosentan",
"start_marketing_date": "20250818",
"active_numerator_strength": "32"
}Related drugs
Other records sharing ATC code C02KX01.
Access this data programmatically
Query Bosentan and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.