ambrisentan

Generic: ambrisentan

Labeler: a-s medication solutions
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ambrisentan
Generic Name ambrisentan
Labeler a-s medication solutions
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

ambrisentan 10 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-7670
Product ID 50090-7670_0a07dd73-2271-409b-a0b4-de0db982250e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216531
Listing Expiration 2026-12-31
Marketing Start 2022-07-21

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 500907670
Hyphenated Format 50090-7670

Supplemental Identifiers

RxCUI
722116
UNII
HW6NV07QEC
NUI
N0000175581 N0000175364

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 ANDA216531 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (50090-7670-0)
source: ndc

Packages (1)

50090-7670-0 30 TABLET, FILM COATED in 1 BOTTLE (50090-7670-0)

Ingredients (1)

ambrisentan (10 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": "0a07dd73-2271-409b-a0b4-de0db982250e", "openfda": {"nui": ["N0000175581", "N0000175364"], "unii": ["HW6NV07QEC"], "rxcui": ["722116"], "spl_set_id": ["a7dcdea4-d3da-4dc1-9193-6ebdb5b4e690"], "pharm_class_epc": ["Endothelin Receptor Antagonist [EPC]"], "pharm_class_moa": ["Endothelin Receptor Antagonists [MoA]"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (50090-7670-0)", "package_ndc": "50090-7670-0", "marketing_start_date": "20251007"}], "brand_name": "ambrisentan", "product_id": "50090-7670_0a07dd73-2271-409b-a0b4-de0db982250e", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Endothelin Receptor Antagonist [EPC]", "Endothelin Receptor Antagonists [MoA]"], "product_ndc": "50090-7670", "generic_name": "ambrisentan", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ambrisentan", "active_ingredients": [{"name": "AMBRISENTAN", "strength": "10 mg/1"}], "application_number": "ANDA216531", "marketing_category": "ANDA", "marketing_start_date": "20220721", "listing_expiration_date": "20261231"}