Active ingredient
Gadoterate Meglumine
14 finished FDA listings contain Gadoterate Meglumine as their only active ingredient.
At a glance
From the FDA NDC Directory
- Ingredient names as written by FDA
- GADOTERATE MEGLUMINE
- Dosage forms
- Injection, Injection, Solution
- Routes
- Intravenous
- Manufacturers / labelers
- 4
- Strengths listed
- 376.9 mg/ml
- Brand names in FDA listings
- Clariscan, Dotarem
Official drug information
Source coverage for Gadoterate Meglumine:
- FDA NDC Directory: linked
- RxNorm: linked
- Drugs@FDA: linked
- DailyMed: linked
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 1421151
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
- Application
- NDA 204781
- Sponsor
- GUERBET
- Original approval
- 2013-03-20
- Listings
- 5
- Application
- ANDA 210016
- Sponsor
- GE HEALTHCARE
- Original approval
- 2019-11-01
- Listings
- 2
- Application
- ANDA 215304
- Sponsor
- HENGRUI PHARMA
- Original approval
- 2022-04-11
- Listings
- 4
- Application
- ANDA 218073
- Sponsor
- HAINAN POLY
- Original approval
- 2024-06-17
- Listings
- 2
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 204781 | GUERBET | 2013-03-20 | 5 |
| ANDA 210016 | GE HEALTHCARE | 2019-11-01 | 2 |
| ANDA 215304 | HENGRUI PHARMA | 2022-04-11 | 4 |
| ANDA 218073 | HAINAN POLY | 2024-06-17 | 2 |
Official labeling on DailyMed
- CLARISCAN (GADOTERATE MEGLUMINE) INJECTION, SOLUTION [GE HEALTHCARE] · version 16 · 2026-05-20
- CLARISCAN (GADOTERATE MEGLUMINE) INJECTION, SOLUTION [GE HEALTHCARE] · version 12 · 2026-05-20
- GADOTERATE MEGLUMINE INJECTION [FRESENIUS KABI USA, LLC] · version 2 · 2025-11-27
- GADOTERATE MEGLUMINE INJECTION [FRESENIUS KABI USA, LLC] · version 4 · 2025-11-21
- GADOTERATE MEGLUMINE INJECTION [SLATE RUN PHARMACEUTICALS, LLC] · version 4 · 2025-04-22
- GADOTERATE MEGLUMINE INJECTION [SLATE RUN PHARMACEUTICALS, LLC] · version 4 · 2025-04-22
- DOTAREM (GADOTERATE MEGLUMINE) INJECTION [GUERBET LLC] · version 25 · 2025-03-21
- DOTAREM (GADOTERATE MEGLUMINE) INJECTION [GUERBET LLC] · version 17 · 2025-03-21
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.