bosentan

Generic: bosentan

Labeler: lupin pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name bosentan
Generic Name bosentan
Labeler lupin pharmaceuticals, inc.
Dosage Form TABLET, FOR SUSPENSION
Routes
ORAL
Active Ingredients

bosentan 32 mg/1

Manufacturer
Lupin Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68180-340
Product ID 68180-340_063d2028-f666-4304-8cd3-21d882d8c97f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213154
Listing Expiration 2026-12-31
Marketing Start 2025-08-18

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 68180340
Hyphenated Format 68180-340

Supplemental Identifiers

RxCUI
1989081
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 ANDA213154 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 32 mg/1
source: ndc
Packaging
  • 4 BLISTER PACK in 1 CARTON (68180-340-13) / 14 TABLET, FOR SUSPENSION in 1 BLISTER PACK
source: ndc

Packages (1)

68180-340-13 4 BLISTER PACK in 1 CARTON (68180-340-13) / 14 TABLET, FOR SUSPENSION in 1 BLISTER PACK

Ingredients (1)

bosentan (32 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": "063d2028-f666-4304-8cd3-21d882d8c97f", "openfda": {"unii": ["Q326023R30"], "rxcui": ["1989081"], "spl_set_id": ["540b6f6a-79f3-4681-8c2a-268cf7cecbc9"], "manufacturer_name": ["Lupin Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "4 BLISTER PACK in 1 CARTON (68180-340-13)  / 14 TABLET, FOR SUSPENSION in 1 BLISTER PACK", "package_ndc": "68180-340-13", "marketing_start_date": "20250818"}], "brand_name": "Bosentan", "product_id": "68180-340_063d2028-f666-4304-8cd3-21d882d8c97f", "dosage_form": "TABLET, FOR SUSPENSION", "pharm_class": ["Cytochrome P450 2C9 Inducers [MoA]", "Cytochrome P450 3A Inducers [MoA]", "Endothelin Receptor Antagonist [EPC]", "Endothelin Receptor Antagonists [MoA]"], "product_ndc": "68180-340", "generic_name": "Bosentan", "labeler_name": "Lupin Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bosentan", "active_ingredients": [{"name": "BOSENTAN", "strength": "32 mg/1"}], "application_number": "ANDA213154", "marketing_category": "ANDA", "marketing_start_date": "20250818", "listing_expiration_date": "20261231"}