Package 50419-325-15
Brand: gadavist
Generic: gadobutrolPackage Facts
Identity
Package NDC
50419-325-15
Digits Only
5041932515
Product NDC
50419-325
Description
10 BOTTLE, GLASS in 1 BOX (50419-325-15) / 65 mL in 1 BOTTLE, GLASS
Marketing
Marketing Status
Brand
gadavist
Generic
gadobutrol
Sample Package
No
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["INTRAVENOUS"], "spl_id": "bc993d5e-eb19-4cf2-b20c-9fa6bfede708", "openfda": {"nui": ["N0000183362", "N0000175862"], "unii": ["1BJ477IO2L"], "spl_set_id": ["bd28560f-de4d-4140-874e-31df823f4dbb"], "pharm_class_epc": ["Gadolinium-based Contrast Agent [EPC]"], "pharm_class_moa": ["Magnetic Resonance Contrast Activity [MoA]"], "manufacturer_name": ["Bayer HealthCare Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 BOTTLE, GLASS in 1 BOX (50419-325-15) / 65 mL in 1 BOTTLE, GLASS", "package_ndc": "50419-325-15", "marketing_end_date": "20260330", "marketing_start_date": "20110315"}], "brand_name": "Gadavist", "product_id": "50419-325_bc993d5e-eb19-4cf2-b20c-9fa6bfede708", "dosage_form": "INJECTION", "pharm_class": ["Gadolinium-based Contrast Agent [EPC]", "Magnetic Resonance Contrast Activity [MoA]"], "product_ndc": "50419-325", "generic_name": "gadobutrol", "labeler_name": "Bayer HealthCare Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gadavist", "active_ingredients": [{"name": "GADOBUTROL", "strength": "604.72 mg/mL"}], "application_number": "NDA201277", "marketing_category": "NDA", "marketing_start_date": "20110314", "listing_expiration_date": "20271231"}