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Prescription medicine · generic available

Betaine

Brand names: Cystadane

Drug class: Methylating Agent

The FDA’s “Established Pharmacologic Class”: the group of medicines that work in a similar way.

Full FDA label All drugs

Official FDA data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the drug label, the NDC Directory, Drugs@FDA, recall reports and the drug shortage list. Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

At a glance

NoBoxed warning
None listedFDA shortage list
0Recalls (FDA reports)
3Companies
1996First FDA approval on file

Quick answers

What is Betaine used for?
The FDA-approved label (Cystadane, Recordati Rare Diseases, April 24, 2026) says: “CYSTADANE ® 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 …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Betaine have a boxed warning?
No. None of the 3 FDA labels we found for this medicine has a boxed warning.
Is there a shortage of Betaine?
No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
Has Betaine been recalled?
No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
Who makes Betaine?
3 companies list prescription products of Betaine in the FDA NDC Directory, including Eton Pharmaceuticals, Inc., Cosette Pharmaceuticals, Inc. and Recordati Rare Diseases.

What Betaine is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

CYSTADANE ® 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 …

— FDA label: Cystadane, Recordati Rare Diseases, effective April 24, 2026. Read the full label on DailyMed →

The FDA has 3 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

Boxed warning

A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.

The label quoted above has no boxed warning.

0 of 3 FDA labels for this medicine have a boxed warning.

Forms and how it is given

Dosage formsPowder, for solution
RouteOral
Prescription products3 in the FDA NDC Directory
Brand namesCystadane

Companies that list this medicine

Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.

FDA approval history

  • NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
  • ANDA: Abbreviated New Drug Application: how a generic version is approved.
Brand and biologic applications
ApplicationSponsorApprovedLater changes approved
NDA020576
CYSTADANE		 Recordati RareOctober 25, 1996 8, latest November 6, 2018
2018: Labeling · 2010: Labeling · 2006: Labeling

Generic approvals (2)

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

Recalls

No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.

Official identifiers

RxCUI (RxNorm)404539, 562847
SPL set ID of the quoted label31a684d0-cd98-4e46-b43a-ccbd17c41559
FDA labels (SPL)3
FDA applicationsNDA020576, 2 ANDA
Active ingredients (FDA)BETAINE

Sources

  1. FDA-approved label on DailyMed (National Library of Medicine) — Cystadane, Recordati Rare Diseases, effective April 24, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
  2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026

openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →

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