Package 68382-447-05
Brand: bosentan
Generic: bosentanPackage Facts
Identity
Package NDC
68382-447-05
Digits Only
6838244705
Product NDC
68382-447
Description
500 TABLET, COATED in 1 BOTTLE (68382-447-05)
Marketing
Marketing Status
Brand
bosentan
Generic
bosentan
Sample Package
No
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "f6180792-cb7a-46ef-b2bb-4a819e4901bb", "openfda": {"unii": ["Q326023R30"], "rxcui": ["349253", "656659"], "spl_set_id": ["8444da17-6c31-492b-8842-93740f083d9d"], "manufacturer_name": ["Zydus Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, COATED in 1 BOTTLE (68382-447-01)", "package_ndc": "68382-447-01", "marketing_start_date": "20190501"}, {"sample": false, "description": "500 TABLET, COATED in 1 BOTTLE (68382-447-05)", "package_ndc": "68382-447-05", "marketing_start_date": "20190501"}, {"sample": false, "description": "60 TABLET, COATED in 1 BOTTLE (68382-447-14)", "package_ndc": "68382-447-14", "marketing_start_date": "20190501"}, {"sample": false, "description": "180 TABLET, COATED in 1 BOTTLE (68382-447-28)", "package_ndc": "68382-447-28", "marketing_start_date": "20190501"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (68382-447-77) / 10 TABLET, COATED in 1 BLISTER PACK (68382-447-30)", "package_ndc": "68382-447-77", "marketing_start_date": "20190501"}], "brand_name": "Bosentan", "product_id": "68382-447_f6180792-cb7a-46ef-b2bb-4a819e4901bb", "dosage_form": "TABLET, COATED", "pharm_class": ["Cytochrome P450 2C9 Inducers [MoA]", "Cytochrome P450 3A Inducers [MoA]", "Endothelin Receptor Antagonist [EPC]", "Endothelin Receptor Antagonists [MoA]"], "product_ndc": "68382-447", "generic_name": "Bosentan", "labeler_name": "Zydus Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bosentan", "active_ingredients": [{"name": "BOSENTAN", "strength": "125 mg/1"}], "application_number": "ANDA207760", "marketing_category": "ANDA", "marketing_start_date": "20190501", "listing_expiration_date": "20261231"}