tracleer

Generic: bosentan

Labeler: actelion pharmaceuticals us, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name tracleer
Generic Name bosentan
Labeler actelion pharmaceuticals us, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

bosentan 125 mg/1

Manufacturer
Actelion Pharmaceuticals US, Inc.

Identifiers & Regulatory

Product NDC 66215-102
Product ID 66215-102_f52a8c9c-529d-4bd8-9bfb-d91161935c20
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021290
Listing Expiration 2027-12-31
Marketing Start 2001-11-20

Pharmacologic Class

Classes
cytochrome p450 2c9 inducers [moa] cytochrome p450 3a inducers [moa] endothelin receptor antagonist [epc] endothelin receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 66215102
Hyphenated Format 66215-102

Supplemental Identifiers

RxCUI
349253 352066 656659 656660 1989081 1989085
UNII
Q326023R30

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name tracleer (source: ndc)
Generic Name bosentan (source: ndc)
Application Number NDA021290 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 125 mg/1
source: ndc
Packaging
  • 10 BLISTER PACK in 1 CARTON (66215-102-03) / 3 TABLET, FILM COATED in 1 BLISTER PACK
  • 1 BOTTLE, PLASTIC in 1 CARTON (66215-102-06) / 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
source: ndc

Packages (2)

66215-102-03 10 BLISTER PACK in 1 CARTON (66215-102-03) / 3 TABLET, FILM COATED in 1 BLISTER PACK 66215-102-06 1 BOTTLE, PLASTIC in 1 CARTON (66215-102-06) / 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

Ingredients (1)

bosentan (125 mg/1)

Linked Drug Pages (1)

Tracleer ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "f52a8c9c-529d-4bd8-9bfb-d91161935c20", "openfda": {"unii": ["Q326023R30"], "rxcui": ["349253", "352066", "656659", "656660", "1989081", "1989085"], "spl_set_id": ["749e42fb-2fe0-45dd-9268-b43bb3f4081c"], "manufacturer_name": ["Actelion Pharmaceuticals US, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 BLISTER PACK in 1 CARTON (66215-102-03)  / 3 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "66215-102-03", "marketing_start_date": "20121002"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (66215-102-06)  / 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC", "package_ndc": "66215-102-06", "marketing_start_date": "20011120"}], "brand_name": "Tracleer", "product_id": "66215-102_f52a8c9c-529d-4bd8-9bfb-d91161935c20", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cytochrome P450 2C9 Inducers [MoA]", "Cytochrome P450 3A Inducers [MoA]", "Endothelin Receptor Antagonist [EPC]", "Endothelin Receptor Antagonists [MoA]"], "product_ndc": "66215-102", "generic_name": "bosentan", "labeler_name": "Actelion Pharmaceuticals US, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tracleer", "active_ingredients": [{"name": "BOSENTAN", "strength": "125 mg/1"}], "application_number": "NDA021290", "marketing_category": "NDA", "marketing_start_date": "20011120", "listing_expiration_date": "20271231"}