Package 67684-2001-2

Brand: dotarem

Generic: gadoterate meglumine
NDC Package

Package Facts

Identity

Package NDC 67684-2001-2
Digits Only 6768420012
Product NDC 67684-2001
Description

10 VIAL in 1 PACKAGE (67684-2001-2) / 15 mL in 1 VIAL

Marketing

Marketing Status
Marketed Since 2019-10-24
Brand dotarem
Generic gadoterate meglumine
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["INTRAVENOUS"], "spl_id": "313093fe-89fb-4ca8-973c-f36175bb47df", "openfda": {"upc": ["0367684200110", "0367684300124", "0367684300117", "0367684300131", "0367684200103", "0367684200134", "0367684200127"], "unii": ["L0ND3981AG"], "spl_set_id": ["e2c4a5ac-2df2-4cf4-a2d3-6fbe2d898ebc"], "manufacturer_name": ["Guerbet LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 PACKAGE (67684-2001-0)  / 5 mL in 1 VIAL", "package_ndc": "67684-2001-0", "marketing_start_date": "20191024"}, {"sample": false, "description": "10 VIAL in 1 PACKAGE (67684-2001-1)  / 10 mL in 1 VIAL", "package_ndc": "67684-2001-1", "marketing_start_date": "20191024"}, {"sample": false, "description": "10 VIAL in 1 PACKAGE (67684-2001-2)  / 15 mL in 1 VIAL", "package_ndc": "67684-2001-2", "marketing_start_date": "20191024"}, {"sample": false, "description": "10 VIAL in 1 PACKAGE (67684-2001-3)  / 20 mL in 1 VIAL", "package_ndc": "67684-2001-3", "marketing_start_date": "20191024"}], "brand_name": "DOTAREM", "product_id": "67684-2001_313093fe-89fb-4ca8-973c-f36175bb47df", "dosage_form": "INJECTION", "pharm_class": ["Gadolinium-based Contrast Agent [EPC]", "Magnetic Resonance Contrast Activity [MoA]"], "product_ndc": "67684-2001", "generic_name": "gadoterate meglumine", "labeler_name": "Guerbet LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DOTAREM", "active_ingredients": [{"name": "GADOTERATE MEGLUMINE", "strength": "376.9 mg/mL"}], "application_number": "NDA204781", "marketing_category": "NDA", "marketing_start_date": "20130320", "listing_expiration_date": "20261231"}