ambrisentan

Generic: ambrisentan

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

Drug Facts

Product Profile

Brand Name ambrisentan
Generic Name ambrisentan
Labeler zydus lifesciences limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

ambrisentan 5 mg/1

Manufacturer
Zydus Lifesciences Limited

Identifiers & Regulatory

Product NDC 70771-1363
Product ID 70771-1363_14a85c38-61bf-4621-8e3a-34ab57a15758
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210058
Listing Expiration 2026-12-31
Marketing Start 2019-04-12

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 707711363
Hyphenated Format 70771-1363

Supplemental Identifiers

RxCUI
722116 722122
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 ambrisentan (source: ndc)
Generic Name ambrisentan (source: ndc)
Application Number ANDA210058 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (70771-1363-1)
  • 30 TABLET, FILM COATED in 1 BOTTLE (70771-1363-3)
  • 1 BLISTER PACK in 1 CARTON (70771-1363-7) / 10 TABLET, FILM COATED in 1 BLISTER PACK
  • 3 BLISTER PACK in 1 CARTON (70771-1363-8) / 10 TABLET, FILM COATED in 1 BLISTER PACK
  • 90 TABLET, FILM COATED in 1 BOTTLE (70771-1363-9)
source: ndc

Packages (5)

70771-1363-1 100 TABLET, FILM COATED in 1 BOTTLE (70771-1363-1) 70771-1363-3 30 TABLET, FILM COATED in 1 BOTTLE (70771-1363-3) 70771-1363-7 1 BLISTER PACK in 1 CARTON (70771-1363-7) / 10 TABLET, FILM COATED in 1 BLISTER PACK 70771-1363-8 3 BLISTER PACK in 1 CARTON (70771-1363-8) / 10 TABLET, FILM COATED in 1 BLISTER PACK 70771-1363-9 90 TABLET, FILM COATED in 1 BOTTLE (70771-1363-9)

Ingredients (1)

ambrisentan (5 mg/1)

Linked Drug Pages (1)

Ambrisentan ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "14a85c38-61bf-4621-8e3a-34ab57a15758", "openfda": {"nui": ["N0000175581", "N0000175364"], "unii": ["HW6NV07QEC"], "rxcui": ["722116", "722122"], "spl_set_id": ["0e3e3320-27ac-404f-9f01-3d82696e768a"], "pharm_class_epc": ["Endothelin Receptor Antagonist [EPC]"], "pharm_class_moa": ["Endothelin Receptor Antagonists [MoA]"], "manufacturer_name": ["Zydus Lifesciences Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (70771-1363-1)", "package_ndc": "70771-1363-1", "marketing_start_date": "20190412"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (70771-1363-3)", "package_ndc": "70771-1363-3", "marketing_start_date": "20190412"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (70771-1363-7)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "70771-1363-7", "marketing_start_date": "20190412"}, {"sample": false, "description": "3 BLISTER PACK in 1 CARTON (70771-1363-8)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "70771-1363-8", "marketing_start_date": "20190412"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (70771-1363-9)", "package_ndc": "70771-1363-9", "marketing_start_date": "20190412"}], "brand_name": "Ambrisentan", "product_id": "70771-1363_14a85c38-61bf-4621-8e3a-34ab57a15758", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Endothelin Receptor Antagonist [EPC]", "Endothelin Receptor Antagonists [MoA]"], "product_ndc": "70771-1363", "generic_name": "Ambrisentan", "labeler_name": "Zydus Lifesciences Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ambrisentan", "active_ingredients": [{"name": "AMBRISENTAN", "strength": "5 mg/1"}], "application_number": "ANDA210058", "marketing_category": "ANDA", "marketing_start_date": "20190412", "listing_expiration_date": "20261231"}