Package 65219-084-15

Brand: gadoterate meglumine

Generic: gadoterate meglumine
NDC Package

Package Facts

Identity

Package NDC 65219-084-15
Digits Only 6521908415
Product NDC 65219-084
Product ID 65219-084_f05922b7-99d4-48c7-972a-7966bbbbc3b4
Description

10 CARTON in 1 BOX (65219-084-15) / 1 VIAL in 1 CARTON (65219-084-01) / 15 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)

Gadoterate Meglumine ndc-match (0.95)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "f05922b7-99d4-48c7-972a-7966bbbbc3b4", "openfda": {"upc": ["0365219086017", "0365219084013", "0365219080015", "0365219082019"], "unii": ["L0ND3981AG"], "spl_set_id": ["e0655aac-9508-4141-94f5-fcca6af1c41d"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 CARTON in 1 BOX (65219-084-15)  / 1 VIAL in 1 CARTON (65219-084-01)  / 15 mL in 1 VIAL", "package_ndc": "65219-084-15", "marketing_start_date": "20220620"}], "brand_name": "Gadoterate Meglumine", "product_id": "65219-084_f05922b7-99d4-48c7-972a-7966bbbbc3b4", "dosage_form": "INJECTION", "pharm_class": ["Gadolinium-based Contrast Agent [EPC]", "Magnetic Resonance Contrast Activity [MoA]"], "product_ndc": "65219-084", "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": "ANDA215304", "marketing_category": "ANDA", "marketing_start_date": "20220620", "listing_expiration_date": "20261231"}