FDA Orange Book
Is there a generic for Clarinex-d 12 Hour?
Clarinex-d 12 Hour contains desloratadine and pseudoephedrine. 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
No. The Orange Book lists no active FDA-approved generic (ANDA) for Clarinex-d 12 Hour (desloratadine and pseudoephedrine).
Run it in Rivvi
Map Clarinex-d 12 Hour and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Clarinex-d 12 Hour products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, extended release, oral | 2.5MG;120MG | Marketed (Rx) | None | 0 | None |
NDA 021313, held by ORGANON LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Clarinex-d 12 Hour NDC codes
Questions
Is there a generic for Clarinex-d 12 Hour?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Clarinex-d 12 Hour (desloratadine and pseudoephedrine).
What is the generic name for Clarinex-d 12 Hour?
The active ingredient in Clarinex-d 12 Hour is desloratadine and pseudoephedrine, 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.