Prescription medicine
Betaine Brand names: Cystadane
Betaine (Cystadane) is a prescription medicine with an FDA approval on record since 1996. FDA's NDC Directory lists it from 2 generic labelers.
- Generic listed
Check it at the source: the betaine FDA label on DailyMed (effective April 24, 2026, Recordati Rare Diseases); the NDA 20576 record on Drugs@FDA; every betaine label on DailyMed.
Highlights of the record
FDA label of April 24, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageCYSTADANE ® is indicated for the treatment of homocystinuria to decrease elevated homocysteine blood concentrations in pediatric and adult patients.
Forms and strengths
- 1 g/g
Powder for solution.
On the market
- Earliest approval on file
- October 25, 1996 Cystadane, Recordati Rare; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 2 first November 23, 2021; 2 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 3 of which 2 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 1,036 through July 30, 2026
What is betaine used for?
From the label: indications and usageCYSTADANE ® is indicated for the treatment of homocystinuria to decrease elevated homocysteine blood concentrations in pediatric and adult patients. Included within the category of homocystinuria are: Cystathionine beta-synthase (CBS) deficiency 5,10-methylenetetrahydrofolate reductase (MTHFR) deficiency Cobalamin cofactor metabolism (cbl) defect CYSTADANE is a methylating agent indicated in pediatric and adult patients for the treatment of homocystinuria to decrease elevated homocysteine blood concentrations. […]
FDA pharmacologic class: Methylating Agent.
Source: FDA drug label (Cystadane), Recordati Rare Diseases, effective April 24, 2026 (SPL set 31a684d0-cd98-4e46-b43a-ccbd17c41559), via openFDA; the full label on DailyMed
Is there a generic for betaine (Cystadane)?
The FDA approved the first generic betaine on November 23, 2021. 2 generic applications are approved; 2 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists betaine from 2 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1996 earliest approval on file
- 2021 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for betaine?
The FDA Adverse Event Reporting System holds 1,036 reports that list betaine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 71 are coded as a death and 397 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Betaine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other