Package 65219-088-50

Brand: gadoterate meglumine

Generic: gadoterate meglumine
NDC Package

Package Facts

Identity

Package NDC 65219-088-50
Digits Only 6521908850
Product NDC 65219-088
Description

6 CARTON in 1 BOX (65219-088-50) / 1 VIAL in 1 CARTON (65219-088-06) / 100 mL in 1 VIAL

Marketing

Marketing Status
Marketed Since 2022-06-20
Brand gadoterate meglumine
Generic gadoterate meglumine
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["INTRAVENOUS"], "spl_id": "8b9a98ef-bee6-43fc-a39d-2e5a3c226653", "openfda": {"upc": ["0365219088066"], "unii": ["L0ND3981AG"], "spl_set_id": ["fbebe7f2-a0c2-4fd5-b421-8fbcbaf46709"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "6 CARTON in 1 BOX (65219-088-50)  / 1 VIAL in 1 CARTON (65219-088-06)  / 100 mL in 1 VIAL", "package_ndc": "65219-088-50", "marketing_start_date": "20220620"}], "brand_name": "Gadoterate Meglumine", "product_id": "65219-088_8b9a98ef-bee6-43fc-a39d-2e5a3c226653", "dosage_form": "INJECTION", "pharm_class": ["Gadolinium-based Contrast Agent [EPC]", "Magnetic Resonance Contrast Activity [MoA]"], "product_ndc": "65219-088", "generic_name": "gadoterate meglumine", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gadoterate Meglumine", "active_ingredients": [{"name": "GADOTERATE MEGLUMINE", "strength": "376.9 mg/mL"}], "application_number": "ANDA215982", "marketing_category": "ANDA", "marketing_start_date": "20220620", "listing_expiration_date": "20261231"}