FDA Orange Book
Generic for Vistaril
Vistaril contains hydroxyzine. 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 Vistaril is hydroxyzine. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 5 of the 6 Vistaril products the Orange Book lists.
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Vistaril products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | EQ 100MG HYDROCHLORIDE | Discontinued | None | 1 | None |
| capsule, oral | EQ 25MG HYDROCHLORIDE | Discontinued | None | 4 | AB |
| capsule, oral | EQ 50MG HYDROCHLORIDE | Discontinued | None | 4 | AB |
| injectable, injection | 25MG/ML | Discontinued | None | 1 | None |
| injectable, injection | 50MG/ML | Discontinued | None | 1 | None |
| suspension, oral | EQ 25MG HYDROCHLORIDE/5ML | Discontinued | None | 0 | None |
NDA 011459, 011111, 011795, held by PFIZER LABORATORIES DIV PFIZER INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic hydroxyzine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| BARR LABORATORIES LLC (AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC) | 088488 | None (No TE code listed) | June 15, 1984 | EQ 100MG HYDROCHLORIDE |
| BARR LABORATORIES INC | 088496 | AB (A-rated, therapeutically equivalent) | June 15, 1984 | EQ 25MG HYDROCHLORIDE |
| BARR LABORATORIES LLC (AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC) | 088487 | AB (A-rated, therapeutically equivalent) | June 15, 1984 | EQ 50MG HYDROCHLORIDE |
| IMPAX LABORATORIES INC | 040156 | AB (A-rated, therapeutically equivalent) | July 15, 1996 | EQ 25MG HYDROCHLORIDE, EQ 50MG HYDROCHLORIDE |
| HERITAGE PHARMA LABS INC | 201507 | AB (A-rated, therapeutically equivalent) | June 3, 2013 | EQ 25MG HYDROCHLORIDE, EQ 50MG HYDROCHLORIDE |
| SANDOZ INC | 087479 | AB (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | EQ 25MG HYDROCHLORIDE |
| SANDOZ INC | 086183 | AB (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | EQ 50MG HYDROCHLORIDE |
| AMERICAN REGENT INC | 087408 | None (No TE code listed) | Approved Prior to Jan 1, 1982 | 25MG/ML, 50MG/ML |
Questions
Is there a generic for Vistaril?
Yes. The generic name for Vistaril is hydroxyzine. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 5 of the 6 Vistaril products the Orange Book lists.
What is the generic name for Vistaril?
The active ingredient in Vistaril is hydroxyzine, 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.