Package 70436-123-80
Brand: gadoterate meglumine
Generic: gadoterate megluminePackage Facts
Identity
Package NDC
70436-123-80
Digits Only
7043612380
Product NDC
70436-123
Description
1 VIAL in 1 CARTON (70436-123-80) / 100 mL in 1 VIAL (70436-123-40)
Marketing
Marketing Status
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": "32f1564f-e077-5f10-e063-6394a90afd33", "openfda": {"unii": ["L0ND3981AG"], "spl_set_id": ["b4159c07-b114-4256-b9a9-e6af811704fa"], "manufacturer_name": ["Slate Run Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "6 VIAL in 1 CARTON (70436-123-56) / 100 mL in 1 VIAL (70436-123-40)", "package_ndc": "70436-123-56", "marketing_start_date": "20240801"}, {"sample": false, "description": "1 VIAL in 1 CARTON (70436-123-80) / 100 mL in 1 VIAL (70436-123-40)", "package_ndc": "70436-123-80", "marketing_start_date": "20240628"}], "brand_name": "gadoterate meglumine", "product_id": "70436-123_32f1564f-e077-5f10-e063-6394a90afd33", "dosage_form": "INJECTION", "pharm_class": ["Gadolinium-based Contrast Agent [EPC]", "Magnetic Resonance Contrast Activity [MoA]"], "product_ndc": "70436-123", "generic_name": "gadoterate meglumine", "labeler_name": "Slate Run Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "gadoterate meglumine", "active_ingredients": [{"name": "GADOTERATE MEGLUMINE", "strength": "376.9 mg/mL"}], "application_number": "ANDA218073", "marketing_category": "ANDA", "marketing_start_date": "20240628", "listing_expiration_date": "20261231"}