Package 67684-2000-4

Brand: dotarem

Generic: gadoterate meglumine
NDC Package

Package Facts

Identity

Package NDC 67684-2000-4
Digits Only 6768420004
Product NDC 67684-2000
Product ID 67684-2000_541cb475-4dbe-4348-a96b-593cd957a183
Description

6 VIAL in 1 PACKAGE (67684-2000-4) / 100 mL in 1 VIAL

Marketing

Marketing Status
Marketed Since 2013-04-26
Brand dotarem
Generic gadoterate meglumine
Sample Package No

Linked Drug Pages (1)

DOTAREM ndc-match (0.95)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "541cb475-4dbe-4348-a96b-593cd957a183", "openfda": {"upc": ["0367684200141"], "unii": ["L0ND3981AG"], "spl_set_id": ["82b83e61-6af8-4225-aa39-8cbf206f65b0"], "manufacturer_name": ["Guerbet LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "6 VIAL in 1 PACKAGE (67684-2000-4)  / 100 mL in 1 VIAL", "package_ndc": "67684-2000-4", "marketing_start_date": "20130426"}], "brand_name": "DOTAREM", "product_id": "67684-2000_541cb475-4dbe-4348-a96b-593cd957a183", "dosage_form": "INJECTION", "pharm_class": ["Gadolinium-based Contrast Agent [EPC]", "Magnetic Resonance Contrast Activity [MoA]"], "product_ndc": "67684-2000", "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": "20130426", "listing_expiration_date": "20261231"}