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United States · US · US:66215-101_f52a8c9c-529d-4bd8-9bfb-d91161935c20
Tracleer
In shortageOrange BookUNIISPLATC C02KX01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerActelion Pharmaceuticals US, Inc.
CountryUS (United States)
ATC codeC02KX01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11662151010310 BLISTER PACK in 1 CARTON (66215-101-03) / 3 TABLET, FILM COATED in 1 BLISTER PACK
- ndc1166215101061 BOTTLE, PLASTIC in 1 CARTON (66215-101-06) / 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Annotations
UNII (FDA Substance ID)
Q326023R30
BOSENTAN
RxCUI 75207
Orange Book
N021290
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": {
"749e42fb-2fe0-45dd-9268-b43bb3f4081c": {
"match": "brand_token",
"title": "TRACLEER (BOSENTAN) TABLET, FILM COATED TRACLEER (BOSENTAN) TABLET, FOR SUSPENSION [ACTELION PHARMACEUTICALS US, INC.]",
"spl_version": "36",
"published_date": "2026-01-23"
}
},
"productid": "66215-101_f52a8c9c-529d-4bd8-9bfb-d91161935c20",
"productndc": "66215-101",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "021290",
"products": [
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "62.5MG",
"product_no": "001",
"approval_date": "Nov 20, 2001"
},
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "125MG",
"product_no": "002",
"approval_date": "Nov 20, 2001"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BOSENTAN",
"shortage_reason": "Bosentan Tablet",
"shortage_status": "current",
"proprietary_name": "Tracleer",
"active_ingred_unit": "mg/1",
"application_number": "NDA021290",
"marketing_category": "NDA",
"nonproprietary_name": "bosentan",
"start_marketing_date": "20011120",
"active_numerator_strength": "62.5"
}Related drugs
Other records sharing ATC code C02KX01.
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