Package 70436-212-80

Brand: gadobutrol

Generic: gadobutrol
NDC Package

Package Facts

Identity

Package NDC 70436-212-80
Digits Only 7043621280
Product NDC 70436-212
Product ID 70436-212_3304f07e-e137-e806-e063-6394a90a8a4a
Description

1 VIAL, SINGLE-DOSE in 1 CARTON (70436-212-80) / 7.5 mL in 1 VIAL, SINGLE-DOSE (70436-212-32)

Marketing

Marketing Status
Marketed Since 2023-10-20
Brand gadobutrol
Generic gadobutrol
Sample Package No

Linked Drug Pages (1)

gadobutrol ndc-match (0.95)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "3304f07e-e137-e806-e063-6394a90a8a4a", "openfda": {"nui": ["N0000183362", "N0000175862"], "unii": ["1BJ477IO2L"], "spl_set_id": ["832e0ae1-4fe1-4dff-9978-c9200bcebb55"], "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": "20 VIAL, SINGLE-DOSE in 1 CARTON (70436-212-54)  / 7.5 mL in 1 VIAL, SINGLE-DOSE (70436-212-32)", "package_ndc": "70436-212-54", "marketing_start_date": "20231020"}, {"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (70436-212-80)  / 7.5 mL in 1 VIAL, SINGLE-DOSE (70436-212-32)", "package_ndc": "70436-212-80", "marketing_start_date": "20231020"}], "brand_name": "gadobutrol", "product_id": "70436-212_3304f07e-e137-e806-e063-6394a90a8a4a", "dosage_form": "INJECTION", "pharm_class": ["Gadolinium-based Contrast Agent [EPC]", "Magnetic Resonance Contrast Activity [MoA]"], "product_ndc": "70436-212", "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": "20231020", "listing_expiration_date": "20261231"}