Package 66215-102-03

Brand: tracleer

Generic: bosentan
NDC Package

Package Facts

Identity

Package NDC 66215-102-03
Digits Only 6621510203
Product NDC 66215-102
Description

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

Marketing

Marketing Status
Marketed Since 2012-10-02
Brand tracleer
Generic bosentan
Sample Package No

Linked Drug Pages (1)

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"}