Package 42794-052-22

Brand: ambrisentan

Generic: ambrisentan
NDC Package

Package Facts

Identity

Package NDC 42794-052-22
Digits Only 4279405222
Product NDC 42794-052
Description

10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (42794-052-22)

Marketing

Marketing Status
Marketed Since 2019-04-10
Brand ambrisentan
Generic ambrisentan
Sample Package No

Linked Drug Pages (1)

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 (42794-052-08)", "package_ndc": "42794-052-08", "marketing_start_date": "20190410"}, {"sample": false, "description": "10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (42794-052-22)", "package_ndc": "42794-052-22", "marketing_start_date": "20190410"}], "brand_name": "AMBRISENTAN", "product_id": "42794-052_f1f20771-a78f-74cf-e053-2995a90a6adf", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Endothelin Receptor Antagonist [EPC]", "Endothelin Receptor Antagonists [MoA]"], "product_ndc": "42794-052", "generic_name": "AMBRISENTAN", "labeler_name": "Sigmapharm Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "AMBRISENTAN", "active_ingredients": [{"name": "AMBRISENTAN", "strength": "10 mg/1"}], "application_number": "ANDA208354", "marketing_category": "ANDA", "marketing_start_date": "20190410", "listing_expiration_date": "20261231"}