FDA Orange Book
Generic for Cystadane
Cystadane contains betaine. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Cystadane is betaine. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Cystadane products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| for solution, oral | 1GM/SCOOPFUL | Marketed (Rx) | AB | 2 | AB |
NDA 020576, held by RECORDATI RARE DISEASES INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic betaine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| NOVITIUM PHARMA LLC | 214864 | AB (A-rated, therapeutically equivalent) | November 23, 2021 | 1GM/SCOOPFUL |
| ETON PHARMACEUTICALS INC | 210508 | AB (A-rated, therapeutically equivalent) | January 28, 2022 | 1GM/SCOOPFUL |
Cystadane NDC codes
Questions
Is there a generic for Cystadane?
Yes. The generic name for Cystadane is betaine. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Cystadane?
The active ingredient in Cystadane is betaine, per the FDA Orange Book.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.