Package 65219-281-07
Brand: gadobutrol
Generic: gadobutrolPackage Facts
Identity
Package NDC
65219-281-07
Digits Only
6521928107
Product NDC
65219-281
Description
2 CARTON in 1 BOX (65219-281-07) / 10 VIAL, SINGLE-DOSE in 1 CARTON / 7.5 mL in 1 VIAL, SINGLE-DOSE (65219-281-03)
Marketing
Marketing Status
Brand
gadobutrol
Generic
gadobutrol
Sample Package
No
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["INTRAVENOUS"], "spl_id": "490c8c3e-3195-40af-8f34-40d8df2719c3", "openfda": {"nui": ["N0000183362", "N0000175862"], "upc": ["0365219281023"], "unii": ["1BJ477IO2L"], "spl_set_id": ["007696d0-4b62-4937-9640-4ad619504df4"], "pharm_class_epc": ["Gadolinium-based Contrast Agent [EPC]"], "pharm_class_moa": ["Magnetic Resonance Contrast Activity [MoA]"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 CARTON in 1 BOX (65219-281-02) / 3 VIAL, SINGLE-DOSE in 1 CARTON / 2 mL in 1 VIAL, SINGLE-DOSE (65219-281-00)", "package_ndc": "65219-281-02", "marketing_start_date": "20230414"}, {"sample": false, "description": "2 CARTON in 1 BOX (65219-281-07) / 10 VIAL, SINGLE-DOSE in 1 CARTON / 7.5 mL in 1 VIAL, SINGLE-DOSE (65219-281-03)", "package_ndc": "65219-281-07", "marketing_start_date": "20230414"}, {"sample": false, "description": "2 CARTON in 1 BOX (65219-281-10) / 10 VIAL, SINGLE-DOSE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-DOSE (65219-281-08)", "package_ndc": "65219-281-10", "marketing_start_date": "20230414"}, {"sample": false, "description": "2 CARTON in 1 BOX (65219-281-15) / 10 VIAL, SINGLE-DOSE in 1 CARTON / 15 mL in 1 VIAL, SINGLE-DOSE (65219-281-05)", "package_ndc": "65219-281-15", "marketing_start_date": "20230414"}], "brand_name": "Gadobutrol", "product_id": "65219-281_490c8c3e-3195-40af-8f34-40d8df2719c3", "dosage_form": "INJECTION", "pharm_class": ["Gadolinium-based Contrast Agent [EPC]", "Magnetic Resonance Contrast Activity [MoA]"], "product_ndc": "65219-281", "generic_name": "Gadobutrol", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gadobutrol", "active_ingredients": [{"name": "GADOBUTROL", "strength": "604.72 mg/mL"}], "application_number": "ANDA215061", "marketing_category": "ANDA", "marketing_start_date": "20230414", "listing_expiration_date": "20261231"}