bosentan

Generic: bosentan

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name bosentan
Generic Name bosentan
Labeler sun pharmaceutical industries, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

bosentan 125 mg/1

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 47335-039
Product ID 47335-039_72ab60fc-63c5-4b1e-93ce-a21f3754e343
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209324
Listing Expiration 2026-12-31
Marketing Start 2019-04-26

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 47335039
Hyphenated Format 47335-039

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 ANDA209324 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 125 mg/1
source: ndc
Packaging
  • 10 BLISTER PACK in 1 CARTON (47335-039-64) / 3 TABLET, FILM COATED in 1 BLISTER PACK (47335-039-60)
  • 60 TABLET, FILM COATED in 1 BOTTLE (47335-039-86)
source: ndc

Packages (2)

47335-039-64 10 BLISTER PACK in 1 CARTON (47335-039-64) / 3 TABLET, FILM COATED in 1 BLISTER PACK (47335-039-60) 47335-039-86 60 TABLET, FILM COATED in 1 BOTTLE (47335-039-86)

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": "72ab60fc-63c5-4b1e-93ce-a21f3754e343", "openfda": {"unii": ["Q326023R30"], "rxcui": ["349253", "656659"], "spl_set_id": ["c006d8ef-8cb7-4fb3-88eb-b2debc302a20"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 BLISTER PACK in 1 CARTON (47335-039-64)  / 3 TABLET, FILM COATED in 1 BLISTER PACK (47335-039-60)", "package_ndc": "47335-039-64", "marketing_start_date": "20190426"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (47335-039-86)", "package_ndc": "47335-039-86", "marketing_start_date": "20190426"}], "brand_name": "Bosentan", "product_id": "47335-039_72ab60fc-63c5-4b1e-93ce-a21f3754e343", "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": "47335-039", "generic_name": "Bosentan", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bosentan", "active_ingredients": [{"name": "BOSENTAN", "strength": "125 mg/1"}], "application_number": "ANDA209324", "marketing_category": "ANDA", "marketing_start_date": "20190426", "listing_expiration_date": "20261231"}