FDA Orange Book
Generic for Atarax
Atarax 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 Atarax is hydroxyzine. 18 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA, AB. Generics match 4 of the 5 Atarax products the Orange Book lists.
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Atarax products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| syrup, oral | 10MG/5ML | Discontinued | None | 8 | AA |
| tablet, oral | 100MG | Discontinued | None | 0 | None |
| tablet, oral | 10MG | Discontinued | None | 11 | AB |
| tablet, oral | 25MG | Discontinued | None | 11 | AB |
| tablet, oral | 50MG | Discontinued | None | 11 | AB |
NDA 010485, 010392, held by ROERIG 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 |
|---|---|---|---|---|
| CHARTWELL RX SCIENCES LLC | 087294 | AA (A-rated, therapeutically equivalent) | April 12, 1982 | 10MG/5ML |
| AUROBINDO PHARMA LTD | 087871 | AB (A-rated, therapeutically equivalent) | December 20, 1982 | 10MG, 25MG, 50MG |
| PLIVA INC | 088617 | AB (A-rated, therapeutically equivalent) | January 10, 1986 | 10MG |
| PLIVA INC | 088618 | AB (A-rated, therapeutically equivalent) | January 10, 1986 | 25MG |
| PLIVA INC | 088619 | AB (A-rated, therapeutically equivalent) | January 10, 1986 | 50MG |
| PAI HOLDINGS LLC DBA PHARMACEUTICAL ASSOCIATES INC | 040391 | AA (A-rated, therapeutically equivalent) | April 10, 2002 | 10MG/5ML |
| EPIC PHARMA LLC | 040604 | AB (A-rated, therapeutically equivalent) | December 28, 2004 | 10MG, 25MG, 50MG |
| PRINSTON PHARMACEUTICAL INC | 040580 | AB (A-rated, therapeutically equivalent) | May 27, 2005 | 10MG, 25MG, 50MG |
| KVK TECH INC | 040786 | AB (A-rated, therapeutically equivalent) | March 20, 2007 | 10MG, 25MG, 50MG |
| NORTHSTAR HEALTHCARE HOLDINGS LTD | 040840 | AB (A-rated, therapeutically equivalent) | March 31, 2008 | 10MG, 25MG, 50MG |
| HETERO LABS LTD UNIT III | 040805 | AB (A-rated, therapeutically equivalent) | May 29, 2008 | 10MG, 25MG, 50MG |
| CHARTWELL RX SCIENCES LLC | 040804 | AB (A-rated, therapeutically equivalent) | June 30, 2008 | 10MG, 25MG, 50MG |
| LANNETT CO INC | 201674 | AA (A-rated, therapeutically equivalent) | August 21, 2013 | 10MG/5ML |
| HERITAGE PHARMACEUTICALS INC DBA AVET PHARMACEUTICALS INC | 204279 | AB (A-rated, therapeutically equivalent) | August 20, 2014 | 10MG, 25MG, 50MG |
| NUVO PHAMACEUTICALS INC | 207121 | AB (A-rated, therapeutically equivalent) | March 29, 2017 | 10MG, 25MG, 50MG |
| PHARMAZONE | 210634 | AA (A-rated, therapeutically equivalent) | February 26, 2019 | 10MG/5ML |
| GRAVITI PHARMACEUTICALS PRIVATE LTD | 217652 | AB (A-rated, therapeutically equivalent) | August 17, 2023 | 10MG, 25MG, 50MG |
| BIONPHARMA INC | 219289 | AA (A-rated, therapeutically equivalent) | April 28, 2025 | 10MG/5ML |
| NOVITIUM PHARMA LLC | 219648 | AA (A-rated, therapeutically equivalent) | December 16, 2025 | 10MG/5ML |
| SCIEGEN PHARMACEUTICALS INC | 220271 | AA (A-rated, therapeutically equivalent) | June 11, 2026 | 10MG/5ML |
| RUBICON RESEARCH LTD | 219561 | AA (A-rated, therapeutically equivalent) | September 11, 2026 | 10MG/5ML |
Questions
Is there a generic for Atarax?
Yes. The generic name for Atarax is hydroxyzine. 18 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA, AB. Generics match 4 of the 5 Atarax products the Orange Book lists.
What is the generic name for Atarax?
The active ingredient in Atarax 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.