FDA Orange Book
Generic for Zyrtec
Zyrtec contains cetirizine. 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 Zyrtec is cetirizine. 9 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA.
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Zyrtec products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, oral | 5MG/5ML | Discontinued | None | 9 | AA |
NDA 020346, held by JOHNSON AND JOHNSON CONSUMER INC MCNEIL CONSUMER HEALTHCARE DIV. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic cetirizine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| PADAGIS US LLC | 078398 | AA (A-rated, therapeutically equivalent) | June 17, 2008 | 5MG/5ML |
| PHARMACEUTICAL ASSOCIATES INC | 078412 | AA (A-rated, therapeutically equivalent) | June 18, 2008 | 5MG/5ML |
| TARO PHARMACEUTICAL INDUSTRIES LTD | 076601 | AA (A-rated, therapeutically equivalent) | June 20, 2008 | 5MG/5ML |
| BIONPHARMA INC | 078488 | AA (A-rated, therapeutically equivalent) | October 6, 2008 | 5MG/5ML |
| PHARMAZONE | 078870 | AA (A-rated, therapeutically equivalent) | April 27, 2009 | 5MG/5ML |
| AMNEAL PHARMACEUTICALS | 090766 | AA (A-rated, therapeutically equivalent) | October 7, 2009 | 5MG/5ML |
| BAJAJ MEDICAL LLC | 090191 | AA (A-rated, therapeutically equivalent) | November 12, 2009 | 5MG/5ML |
| CHARTWELL MOLECULAR HOLDINGS LLC | 078876 | AA (A-rated, therapeutically equivalent) | May 11, 2012 | 5MG/5ML |
| RUBICON RESEARCH LTD | 220335 | AA (A-rated, therapeutically equivalent) | February 25, 2026 | 5MG/5ML |
Questions
Is there a generic for Zyrtec?
Yes. The generic name for Zyrtec is cetirizine. 9 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA.
What is the generic name for Zyrtec?
The active ingredient in Zyrtec is cetirizine, 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.