bosentan

Generic: bosentan

Labeler: actavis pharma, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name bosentan
Generic Name bosentan
Labeler actavis pharma, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

bosentan 62.5 mg/1

Manufacturer
Actavis Pharma, Inc.

Identifiers & Regulatory

Product NDC 0591-2511
Product ID 0591-2511_8f3d0f83-84b4-4860-9478-c86488f41001
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207110
Listing Expiration 2026-12-31
Marketing Start 2019-06-19

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 05912511
Hyphenated Format 0591-2511

Supplemental Identifiers

RxCUI
349253 656659
UPC
0305912512604 0305912511607
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 ANDA207110 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 62.5 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED in 1 BOTTLE (0591-2511-60)
source: ndc

Packages (1)

0591-2511-60 60 TABLET, FILM COATED in 1 BOTTLE (0591-2511-60)

Ingredients (1)

bosentan (62.5 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": "8f3d0f83-84b4-4860-9478-c86488f41001", "openfda": {"upc": ["0305912512604", "0305912511607"], "unii": ["Q326023R30"], "rxcui": ["349253", "656659"], "spl_set_id": ["39b2a85f-4322-42d4-b420-1b1d52569143"], "manufacturer_name": ["Actavis Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (0591-2511-60)", "package_ndc": "0591-2511-60", "marketing_start_date": "20190619"}], "brand_name": "bosentan", "product_id": "0591-2511_8f3d0f83-84b4-4860-9478-c86488f41001", "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": "0591-2511", "generic_name": "bosentan", "labeler_name": "Actavis Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "bosentan", "active_ingredients": [{"name": "BOSENTAN", "strength": "62.5 mg/1"}], "application_number": "ANDA207110", "marketing_category": "ANDA", "marketing_start_date": "20190619", "listing_expiration_date": "20261231"}