FDA Orange Book
Generic for Clarinex
Clarinex contains desloratadine. 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 Clarinex is desloratadine. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Clarinex products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, oral | 0.5MG/ML | Discontinued | None | 1 | None |
| tablet, orally disintegrating, oral | 2.5MG | Discontinued | None | 1 | None |
| tablet, orally disintegrating, oral | 5MG | Discontinued | None | 1 | None |
| tablet, oral | 5MG | Marketed (Rx) | AB | 5 | AB |
NDA 021300, 021312, 021165, held by ORGANON LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic desloratadine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ORBION PHARMACEUTICALS PRIVATE LTD | 078357 | AB (A-rated, therapeutically equivalent) | February 19, 2010 | 5MG |
| DOCTOR REDDYS LABORATORIES LTD | 078367 | None (No TE code listed) | July 12, 2010 | 2.5MG, 5MG |
| LUPIN PHARMACEUTICALS INC | 078352 | AB (A-rated, therapeutically equivalent) | October 25, 2010 | 5MG |
| DR REDDYS LABORATORIES LTD | 078365 | AB (A-rated, therapeutically equivalent) | March 8, 2011 | 5MG |
| NATCO PHARMA USA LLC | 078351 | AB (A-rated, therapeutically equivalent) | February 10, 2012 | 5MG |
| AJENAT PHARMACEUTICALS LLC | 078355 | AB (A-rated, therapeutically equivalent) | April 19, 2012 | 5MG |
| TARO PHARMACEUTICAL INDUSTRIES LTD | 202936 | None (No TE code listed) | May 26, 2016 | 0.5MG/ML |
Clarinex NDC codes
Questions
Is there a generic for Clarinex?
Yes. The generic name for Clarinex is desloratadine. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Clarinex?
The active ingredient in Clarinex is desloratadine, 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.