bosentan

Generic: bosentan

Labeler: zydus lifesciences limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name bosentan
Generic Name bosentan
Labeler zydus lifesciences limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

bosentan 125 mg/1

Manufacturer
Zydus Lifesciences Limited

Identifiers & Regulatory

Product NDC 70771-1018
Product ID 70771-1018_33935d05-c8ff-4d9e-91bf-fac9072d25fd
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 707711018
Hyphenated Format 70771-1018

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 in 1 BOTTLE (70771-1018-1)
  • 10 BLISTER PACK in 1 CARTON (70771-1018-4) / 10 TABLET in 1 BLISTER PACK (70771-1018-2)
  • 500 TABLET in 1 BOTTLE (70771-1018-5)
  • 60 TABLET in 1 BOTTLE (70771-1018-6)
  • 180 TABLET in 1 BOTTLE (70771-1018-8)
source: ndc

Packages (5)

70771-1018-1 100 TABLET in 1 BOTTLE (70771-1018-1) 70771-1018-4 10 BLISTER PACK in 1 CARTON (70771-1018-4) / 10 TABLET in 1 BLISTER PACK (70771-1018-2) 70771-1018-5 500 TABLET in 1 BOTTLE (70771-1018-5) 70771-1018-6 60 TABLET in 1 BOTTLE (70771-1018-6) 70771-1018-8 180 TABLET in 1 BOTTLE (70771-1018-8)

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": "33935d05-c8ff-4d9e-91bf-fac9072d25fd", "openfda": {"unii": ["Q326023R30"], "rxcui": ["349253", "656659"], "spl_set_id": ["02892f47-0d59-4254-9ee7-d524278fdd79"], "manufacturer_name": ["Zydus Lifesciences Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (70771-1018-1)", "package_ndc": "70771-1018-1", "marketing_start_date": "20190501"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (70771-1018-4)  / 10 TABLET in 1 BLISTER PACK (70771-1018-2)", "package_ndc": "70771-1018-4", "marketing_start_date": "20190501"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (70771-1018-5)", "package_ndc": "70771-1018-5", "marketing_start_date": "20190501"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (70771-1018-6)", "package_ndc": "70771-1018-6", "marketing_start_date": "20190501"}, {"sample": false, "description": "180 TABLET in 1 BOTTLE (70771-1018-8)", "package_ndc": "70771-1018-8", "marketing_start_date": "20190501"}], "brand_name": "Bosentan", "product_id": "70771-1018_33935d05-c8ff-4d9e-91bf-fac9072d25fd", "dosage_form": "TABLET", "pharm_class": ["Cytochrome P450 2C9 Inducers [MoA]", "Cytochrome P450 3A Inducers [MoA]", "Endothelin Receptor Antagonist [EPC]", "Endothelin Receptor Antagonists [MoA]"], "product_ndc": "70771-1018", "generic_name": "Bosentan", "labeler_name": "Zydus Lifesciences Limited", "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"}