NDC 67684-2000

Dotarem 376.9 mg per 1 mL injection

On the label: Guerbet LLC.

Where it's made

Astrea Monts

Monts, France · makes it, tests it, packages it and labels it

Serious problems, FDA action Last FDA inspection Oct 18, 2022. 4 inspections on record, 1 with serious problems.

PCAS Finland Oy

Turku, Finland · makes the active ingredient and tests it

Problems found, fixed voluntarily Last FDA inspection Jan 10, 2024. 7 inspections on record.

Simafex

Marans, France · makes the active ingredient

Problems found, fixed voluntarily Last FDA inspection Jan 31, 2025. 5 inspections on record.

Product details

Generic drug

Gadolinium Cation (3+): see every company that makes it

Form

injection, intravenous

Strength

376.9 mg per 1 mL

Approval

NDA NDA204781

On the market since

Mar 20, 2013

Package NDCs

67684-2000-0 67684-2000-1 67684-2000-2 67684-2000-3 67684-2000-5 67684-2000-6 67684-2000-7

Official label

DailyMed (National Library of Medicine), updated Mar 14, 2025

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