Drug
Who makes gadoterate meglumine?
4 companies list gadoterate meglumine as a human prescription drug, including under the names DOTAREM, CLARISCAN. Forms: injection; injection, solution. Routes: intravenous.
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing gadoterate meglumine
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Fresenius Kabi USA, LLCUnited States | injection | ANDAANDA215304, ANDA215982 | 5 | 6 |
| Guerbet LLCFrance | injection | NDANDA204781 | 3 | 2 |
| GE Healthcare Inc.Norway | injection, solution | ANDAANDA210016 | 1 | 5 |
| Slate Run Pharmaceuticals, LLCUnited States | injection | ANDAANDA218073 | 1 | 1 |
Bulk ingredient listings
- Formosa Laboratories, Inc.Taiwan · 1 NDC
- Jiangsu Hengrui Pharmaceuticals Co., Ltd.China · 1 NDC
- Sionc Pharmaceuticals Private LimitedIndia · 1 NDC
Enquiry
Common questions
- Who makes gadoterate meglumine?
- 4 companies list gadoterate meglumine as a human prescription drug in the openFDA NDC Directory, led by Fresenius Kabi USA, LLC, Guerbet LLC, GE Healthcare Inc., Slate Run Pharmaceuticals, LLC. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Is there a generic DOTAREM?
- 3 companies list gadoterate meglumine under an abbreviated new drug application (ANDA), the application type used for generics, and 1 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies gadoterate meglumine active ingredient?
- 3 companies list gadoterate meglumine as a bulk ingredient, including Formosa Laboratories, Inc., Jiangsu Hengrui Pharmaceuticals Co., Ltd., Sionc Pharmaceuticals Private Limited.