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Medicines
United States
Gadoversetamide

FDA 1999

Gadoversetamide

Optimark

16.545GM/50ML, 1654.5MG/5ML, 3309MG/10ML … injectableUnited StatesNot marketedAuthorised 8 Dec 1999

Open in the registerAsk Osler about it

On this page

In other countries
Packs
Documents
Sources and licences

In other countries

The same active substances on other registers, the same brand first.

OptimarkBrazil · Guerbet Imagem do Brasil LtdaSame brand
OptimarkCanada · 330.9 MG / ML · Solution · Liebel-Flarsheim Canada INC · 3 entriesSame brand
OPTIMARK 500 MICROMOL/ml SOLUCION INYECTABLE EN JERINGA PRECARGADASpain · 500 micromol · solución inyectable en jeringa precargada · Mallinckrodt Deutschland Gmbh · 3 entriesSame brand
OptimarkEuropean Union · Mallinckrodt Deutschland GmbHSame brand
Optimark 0.5MMOL-ML Soln. for I.V. InjSaudi Arabia · Liebel Flarsheim Company LLCSame brand
OPTIMARK 0.5MMOL-ML SOLUTION For I.V. Injection*Saudi Arabia · Liebel Flarsheim Company LLC · 2 entriesSame brand

Packs

Two medicines in one question?

Name two or more medicines and Osler runs an interaction check. A severe interaction is stated at the very top of the answer.

Pack	Code	Status

GADOVERSETAMIDE 4963.5MG/15ML (330.9MG/ML)	NDA020937-003	Discontinued
GADOVERSETAMIDE 1654.5MG/5ML (330.9MG/ML)	NDA020937-001	Discontinued
GADOVERSETAMIDE 6618MG/20ML (330.9MG/ML)	NDA020937-004	Discontinued
GADOVERSETAMIDE 3309MG/10ML (330.9MG/ML)	NDA020937-002	Discontinued
GADOVERSETAMIDE 16.545GM/50ML (330.9MG/ML)	NDA020975-001	Discontinued

Documents

The official texts, at the regulator.

Register entryFDA

Sources and licences

Compiled by Prognia from the public register below; the register’s text is the official one.

U.S. Food and Drug Administration (Drugs@FDA) and openFDA drug labels

Source: U.S. Food and Drug Administration, Drugs@FDA and openFDA drug labels (imported 10 June 2026). Not endorsed by the FDA.

Licence: Public domain (U.S. Government work); openFDA terms · Added 10 Jun 2026

Report an error or request removalCorrections from the holder or the register are welcome.

Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.

At a glance

Active substance: Gadoversetamide
Strength: 16.545GM/50ML, 1654.5MG/5ML, 3309MG/10ML, 4963.5MG/15ML, 6618MG/20ML
Dosage form: injectable
Route: injection
Register: United States (FDA)
Status: Not marketed
Status in the register: Discontinued
Authorised: 8 Dec 1999
Registration: NDA 20937
Marketing authorisation holder: Liebel-Flarsheim
Procedure: NDA