ambrisentan

Generic: ambrisentan

Labeler: apotex corp.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ambrisentan
Generic Name ambrisentan
Labeler apotex corp.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

ambrisentan 5 mg/1

Manufacturer
Apotex Corp.

Identifiers & Regulatory

Product NDC 60505-4552
Product ID 60505-4552_9ea6cb4f-0099-f884-4d51-8335310bf1b9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210701
Listing Expiration 2026-12-31
Marketing Start 2022-09-19

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 605054552
Hyphenated Format 60505-4552

Supplemental Identifiers

RxCUI
722116 722122
UPC
0360505455232 0360505455331
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 ANDA210701 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (60505-4552-3)
source: ndc

Packages (1)

60505-4552-3 30 TABLET, FILM COATED in 1 BOTTLE (60505-4552-3)

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": "9ea6cb4f-0099-f884-4d51-8335310bf1b9", "openfda": {"nui": ["N0000175581", "N0000175364"], "upc": ["0360505455232", "0360505455331"], "unii": ["HW6NV07QEC"], "rxcui": ["722116", "722122"], "spl_set_id": ["291a782a-77e1-8a8e-e1c8-2626f305c2b7"], "pharm_class_epc": ["Endothelin Receptor Antagonist [EPC]"], "pharm_class_moa": ["Endothelin Receptor Antagonists [MoA]"], "manufacturer_name": ["Apotex Corp."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (60505-4552-3)", "package_ndc": "60505-4552-3", "marketing_start_date": "20220919"}], "brand_name": "Ambrisentan", "product_id": "60505-4552_9ea6cb4f-0099-f884-4d51-8335310bf1b9", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Endothelin Receptor Antagonist [EPC]", "Endothelin Receptor Antagonists [MoA]"], "product_ndc": "60505-4552", "generic_name": "AMBRISENTAN", "labeler_name": "Apotex Corp.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ambrisentan", "active_ingredients": [{"name": "AMBRISENTAN", "strength": "5 mg/1"}], "application_number": "ANDA210701", "marketing_category": "ANDA", "marketing_start_date": "20220919", "listing_expiration_date": "20261231"}