Drug
Who makes betaine?
2 companies list betaine as a human prescription drug, including under the names Cystadane. Forms: powder, for solution. Routes: oral.
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 betaine
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Recordati Rare DiseasesFrance | powder, for solution | NDANDA020576 | 1 | 1 |
| Cosette Pharmaceuticals, Inc. | powder, for solution | ANDAANDA214864 | 1 | 0 |
Enquiry
Common questions
- Who makes betaine?
- 2 companies list betaine as a human prescription drug in the openFDA NDC Directory, led by Recordati Rare Diseases, Cosette Pharmaceuticals, Inc.. 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 Cystadane?
- 1 company lists betaine 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.