FDA Orange Book
Generic for Xyzal
Xyzal contains levocetirizine. 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 Xyzal is levocetirizine. 11 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA, AB.
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Xyzal products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, oral | 2.5MG/5ML | Discontinued | None | 3 | AA |
| tablet, oral | 5MG | Discontinued | None | 9 | AB |
NDA 022157, 022064, held by CHATTEM INC DBA SANOFI CONSUMER HEALTHCARE. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic levocetirizine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| SYNTHON BV | 090229 | AB (A-rated, therapeutically equivalent) | November 26, 2010 | 5MG |
| DR REDDYS LABORATORIES LIMITED | 090392 | AB (A-rated, therapeutically equivalent) | February 24, 2011 | 5MG |
| GLENMARK PHARMACEUTICALS LTD | 090385 | AB (A-rated, therapeutically equivalent) | February 24, 2011 | 5MG |
| TEVA PHARMACEUTICALS USA | 090199 | AB (A-rated, therapeutically equivalent) | August 22, 2011 | 5MG |
| PADAGIS US LLC | 091263 | AA (A-rated, therapeutically equivalent) | November 7, 2011 | 2.5MG/5ML |
| HETERO LABS LTD UNIT III | 091264 | AB (A-rated, therapeutically equivalent) | June 29, 2012 | 5MG |
| SUN PHARMACEUTICAL INDUSTRIES LTD | 090362 | AB (A-rated, therapeutically equivalent) | January 31, 2013 | 5MG |
| MICRO LABS LTD INDIA | 202046 | AB (A-rated, therapeutically equivalent) | September 17, 2013 | 5MG |
| SCIEGEN PHARMACEUTICALS INC | 203646 | AB (A-rated, therapeutically equivalent) | September 9, 2014 | 5MG |
| MACLEODS PHARMACEUTICALS LTD | 205564 | AB (A-rated, therapeutically equivalent) | January 11, 2016 | 5MG |
| CHARTWELL MOLECULAR HOLDINGS LLC | 204599 | AA (A-rated, therapeutically equivalent) | May 15, 2017 | 2.5MG/5ML |
| HETERO LABS LTD UNIT III | 210914 | AA (A-rated, therapeutically equivalent) | April 1, 2019 | 2.5MG/5ML |
Xyzal NDC codes
Questions
Is there a generic for Xyzal?
Yes. The generic name for Xyzal is levocetirizine. 11 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA, AB.
What is the generic name for Xyzal?
The active ingredient in Xyzal is levocetirizine, 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.