Package 70436-216-51
Brand: gadobutrol
Generic: gadobutrolPackage Facts
Identity
Package NDC
70436-216-51
Digits Only
7043621651
Product NDC
70436-216
Description
5 VIAL, MULTI-DOSE in 1 CARTON (70436-216-51) / 30 mL in 1 VIAL, MULTI-DOSE (70436-216-77)
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": "3304ec39-b300-eb0a-e063-6394a90a1cd1", "openfda": {"nui": ["N0000183362", "N0000175862"], "unii": ["1BJ477IO2L"], "spl_set_id": ["52fbda34-9974-4f9f-9749-6b17d0495b62"], "pharm_class_epc": ["Gadolinium-based Contrast Agent [EPC]"], "pharm_class_moa": ["Magnetic Resonance Contrast Activity [MoA]"], "manufacturer_name": ["Slate Run Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 VIAL, MULTI-DOSE in 1 CARTON (70436-216-51) / 30 mL in 1 VIAL, MULTI-DOSE (70436-216-77)", "package_ndc": "70436-216-51", "marketing_start_date": "20250416"}], "brand_name": "gadobutrol", "product_id": "70436-216_3304ec39-b300-eb0a-e063-6394a90a1cd1", "dosage_form": "INJECTION", "pharm_class": ["Gadolinium-based Contrast Agent [EPC]", "Magnetic Resonance Contrast Activity [MoA]"], "product_ndc": "70436-216", "generic_name": "gadobutrol", "labeler_name": "Slate Run Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "gadobutrol", "active_ingredients": [{"name": "GADOBUTROL", "strength": "604.72 mg/mL"}], "application_number": "ANDA217480", "marketing_category": "ANDA", "marketing_start_date": "20250416", "listing_expiration_date": "20261231"}