bosentan

Generic: bosentan

Labeler: zydus pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name bosentan
Generic Name bosentan
Labeler zydus pharmaceuticals usa inc.
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

bosentan 125 mg/1

Manufacturer
Zydus Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 68382-447
Product ID 68382-447_f6180792-cb7a-46ef-b2bb-4a819e4901bb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207760
Listing Expiration 2026-12-31
Marketing Start 2019-05-01

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 68382447
Hyphenated Format 68382-447

Supplemental Identifiers

RxCUI
349253 656659
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 bosentan (source: ndc)
Generic Name bosentan (source: ndc)
Application Number ANDA207760 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 125 mg/1
source: ndc
Packaging
  • 100 TABLET, COATED in 1 BOTTLE (68382-447-01)
  • 500 TABLET, COATED in 1 BOTTLE (68382-447-05)
  • 60 TABLET, COATED in 1 BOTTLE (68382-447-14)
  • 180 TABLET, COATED in 1 BOTTLE (68382-447-28)
  • 10 BLISTER PACK in 1 CARTON (68382-447-77) / 10 TABLET, COATED in 1 BLISTER PACK (68382-447-30)
source: ndc

Packages (5)

68382-447-01 100 TABLET, COATED in 1 BOTTLE (68382-447-01) 68382-447-05 500 TABLET, COATED in 1 BOTTLE (68382-447-05) 68382-447-14 60 TABLET, COATED in 1 BOTTLE (68382-447-14) 68382-447-28 180 TABLET, COATED in 1 BOTTLE (68382-447-28) 68382-447-77 10 BLISTER PACK in 1 CARTON (68382-447-77) / 10 TABLET, COATED in 1 BLISTER PACK (68382-447-30)

Ingredients (1)

bosentan (125 mg/1)

Linked Drug Pages (1)

Bosentan ndc-match (0.9)

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"}