FDA Orange Book
Generic for Taclonex
Taclonex contains calcipotriene and betamethasone dipropionate. 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 Taclonex is calcipotriene and betamethasone dipropionate. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Taclonex products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| ointment, topical | 0.064%;0.005% | Marketed (Rx) | AB | 1 | AB |
| suspension, topical | 0.064%;0.005% | Marketed (Rx) | AB | 2 | AB |
NDA 021852, 022185, held by LEO PHARMA AS. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic calcipotriene and betamethasone dipropionate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| PADAGIS ISRAEL PHARMACEUTICALS LTD | 200174 | AB (A-rated, therapeutically equivalent) | December 12, 2014 | 0.064%;0.005% |
| COSETTE PHARMACEUTICALS NC LABORATORIES LLC | 210765 | AB (A-rated, therapeutically equivalent) | May 11, 2020 | 0.064%;0.005% |
| SUN PHARMA CANADA INC | 213269 | AB (A-rated, therapeutically equivalent) | September 2, 2020 | 0.064%;0.005% |
Taclonex NDC codes
Questions
Is there a generic for Taclonex?
Yes. The generic name for Taclonex is calcipotriene and betamethasone dipropionate. 3 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 Taclonex?
The active ingredient in Taclonex is calcipotriene and betamethasone dipropionate, 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.