FDA Orange Book
Generic for Aldomet
Aldomet contains methyldopa. 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 Aldomet is methyldopa. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Generics match 2 of the 5 Aldomet products the Orange Book lists.
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Aldomet products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 50MG/ML | Discontinued | None | 0 | None |
| suspension, oral | 250MG/5ML | Discontinued | None | 0 | None |
| tablet, oral | 125MG | Discontinued | None | 0 | None |
| tablet, oral | 250MG | Discontinued | None | 1 | None |
| tablet, oral | 500MG | Discontinued | None | 1 | None |
NDA 013401, 018389, 013400, held by MERCK AND CO INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic methyldopa
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| RISING PHARMA HOLDING INC | 070076 | None (No TE code listed) | April 18, 1985 | 250MG, 500MG |
Questions
Is there a generic for Aldomet?
Yes. The generic name for Aldomet is methyldopa. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Generics match 2 of the 5 Aldomet products the Orange Book lists.
What is the generic name for Aldomet?
The active ingredient in Aldomet is methyldopa, 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.