ambrisentan

Generic: ambrisentan

Labeler: sigmapharm laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ambrisentan
Generic Name ambrisentan
Labeler sigmapharm laboratories, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

ambrisentan 5 mg/1

Manufacturer
Sigmapharm Laboratories, LLC

Identifiers & Regulatory

Product NDC 42794-051
Product ID 42794-051_f1f20771-a78f-74cf-e053-2995a90a6adf
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208354
Listing Expiration 2026-12-31
Marketing Start 2019-04-10

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 42794051
Hyphenated Format 42794-051

Supplemental Identifiers

RxCUI
722116 722122
UPC
0342794052088 0342794051081
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 ANDA208354 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (42794-051-08)
  • 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (42794-051-22)
source: ndc

Packages (2)

42794-051-08 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (42794-051-08) 42794-051-22 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (42794-051-22)

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": "f1f20771-a78f-74cf-e053-2995a90a6adf", "openfda": {"nui": ["N0000175581", "N0000175364"], "upc": ["0342794052088", "0342794051081"], "unii": ["HW6NV07QEC"], "rxcui": ["722116", "722122"], "spl_set_id": ["e20ab2fe-bc9f-48a3-b15a-e4bc9532c2ac"], "pharm_class_epc": ["Endothelin Receptor Antagonist [EPC]"], "pharm_class_moa": ["Endothelin Receptor Antagonists [MoA]"], "manufacturer_name": ["Sigmapharm Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (42794-051-08)", "package_ndc": "42794-051-08", "marketing_start_date": "20190410"}, {"sample": false, "description": "10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (42794-051-22)", "package_ndc": "42794-051-22", "marketing_start_date": "20190410"}], "brand_name": "AMBRISENTAN", "product_id": "42794-051_f1f20771-a78f-74cf-e053-2995a90a6adf", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Endothelin Receptor Antagonist [EPC]", "Endothelin Receptor Antagonists [MoA]"], "product_ndc": "42794-051", "generic_name": "AMBRISENTAN", "labeler_name": "Sigmapharm Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "AMBRISENTAN", "active_ingredients": [{"name": "AMBRISENTAN", "strength": "5 mg/1"}], "application_number": "ANDA208354", "marketing_category": "ANDA", "marketing_start_date": "20190410", "listing_expiration_date": "20261231"}