Package 52015-080-01

Brand: dificid

Generic: fidaxomicin
NDC Package

Package Facts

Identity

Package NDC 52015-080-01
Digits Only 5201508001
Product NDC 52015-080
Description

1 BOTTLE in 1 CARTON (52015-080-01) / 20 TABLET, FILM COATED in 1 BOTTLE

Marketing

Marketing Status
Marketed Since 2011-05-27
Brand dificid
Generic fidaxomicin
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "21c95e9f-0a3d-4fb8-90b5-934bad817d00", "openfda": {"nui": ["M0028311", "N0000175431"], "unii": ["Z5N076G8YQ"], "rxcui": ["1111106", "1111110", "2279843", "2279847"], "spl_set_id": ["dd966338-c820-4270-b704-09ef75fa3ceb"], "pharm_class_cs": ["Macrolides [CS]"], "pharm_class_epc": ["Macrolide Antibacterial [EPC]"], "manufacturer_name": ["Merck Sharp & Dohme LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (52015-080-01)  / 20 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "52015-080-01", "marketing_start_date": "20110527"}], "brand_name": "Dificid", "product_id": "52015-080_21c95e9f-0a3d-4fb8-90b5-934bad817d00", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Macrolide Antibacterial [EPC]", "Macrolides [CS]"], "product_ndc": "52015-080", "generic_name": "fidaxomicin", "labeler_name": "Merck Sharp & Dohme LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dificid", "active_ingredients": [{"name": "FIDAXOMICIN", "strength": "200 mg/1"}], "application_number": "NDA201699", "marketing_category": "NDA", "marketing_start_date": "20110527", "listing_expiration_date": "20261231"}