letairis

Generic: ambrisentan

Labeler: gilead sciences, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name letairis
Generic Name ambrisentan
Labeler gilead sciences, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

ambrisentan 5 mg/1

Manufacturer
Gilead Sciences, Inc.

Identifiers & Regulatory

Product NDC 61958-0801
Product ID 61958-0801_273ba426-0edb-47a2-b5d3-883cd1b9369a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022081
Listing Expiration 2026-12-31
Marketing Start 2007-06-15

Pharmacologic Class

Established (EPC)
endothelin receptor antagonist [epc]
Mechanism of Action
endothelin receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 619580801
Hyphenated Format 61958-0801

Supplemental Identifiers

RxCUI
722116 722120 722122 722124
UNII
HW6NV07QEC
NUI
N0000175581 N0000175364

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 letairis (source: ndc)
Generic Name ambrisentan (source: ndc)
Application Number NDA022081 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-0801-1)
  • 3 BLISTER PACK in 1 CARTON (61958-0801-2) / 10 TABLET, FILM COATED in 1 BLISTER PACK
  • 1 BLISTER PACK in 1 CARTON (61958-0801-3) / 10 TABLET, FILM COATED in 1 BLISTER PACK
  • 1 BLISTER PACK in 1 CARTON (61958-0801-4) / 10 TABLET, FILM COATED in 1 BLISTER PACK
  • 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-0801-5)
  • 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-0801-6)
source: ndc

Packages (6)

61958-0801-1 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-0801-1) 61958-0801-2 3 BLISTER PACK in 1 CARTON (61958-0801-2) / 10 TABLET, FILM COATED in 1 BLISTER PACK 61958-0801-3 1 BLISTER PACK in 1 CARTON (61958-0801-3) / 10 TABLET, FILM COATED in 1 BLISTER PACK 61958-0801-4 1 BLISTER PACK in 1 CARTON (61958-0801-4) / 10 TABLET, FILM COATED in 1 BLISTER PACK 61958-0801-5 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-0801-5) 61958-0801-6 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-0801-6)

Ingredients (1)

ambrisentan (5 mg/1)

Linked Drug Pages (1)

Letairis ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "273ba426-0edb-47a2-b5d3-883cd1b9369a", "openfda": {"nui": ["N0000175581", "N0000175364"], "unii": ["HW6NV07QEC"], "rxcui": ["722116", "722120", "722122", "722124"], "spl_set_id": ["725d4e73-6c83-477a-adc6-0ae4a133a844"], "pharm_class_epc": ["Endothelin Receptor Antagonist [EPC]"], "pharm_class_moa": ["Endothelin Receptor Antagonists [MoA]"], "manufacturer_name": ["Gilead Sciences, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-0801-1)", "package_ndc": "61958-0801-1", "marketing_start_date": "20070615"}, {"sample": false, "description": "3 BLISTER PACK in 1 CARTON (61958-0801-2)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "61958-0801-2", "marketing_start_date": "20070615"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (61958-0801-3)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "61958-0801-3", "marketing_start_date": "20070615"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (61958-0801-4)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "61958-0801-4", "marketing_start_date": "20070615"}, {"sample": false, "description": "10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-0801-5)", "package_ndc": "61958-0801-5", "marketing_start_date": "20070615"}, {"sample": false, "description": "10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-0801-6)", "package_ndc": "61958-0801-6", "marketing_start_date": "20070615"}], "brand_name": "Letairis", "product_id": "61958-0801_273ba426-0edb-47a2-b5d3-883cd1b9369a", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Endothelin Receptor Antagonist [EPC]", "Endothelin Receptor Antagonists [MoA]"], "product_ndc": "61958-0801", "generic_name": "AMBRISENTAN", "labeler_name": "Gilead Sciences, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Letairis", "active_ingredients": [{"name": "AMBRISENTAN", "strength": "5 mg/1"}], "application_number": "NDA022081", "marketing_category": "NDA", "marketing_start_date": "20070615", "listing_expiration_date": "20261231"}