FDA Orange Book
Generic for Cloderm
Cloderm contains clocortolone pivalate. 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 Cloderm is clocortolone pivalate. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Cloderm products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| cream, topical | 0.1% | Marketed (Rx) | AB | 1 | AB |
NDA 017765, held by LEGACY PHARMA INC SEZC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic clocortolone pivalate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| TARO PHARMACEUTICAL INDUSTRIES LTD | 206370 | AB (A-rated, therapeutically equivalent) | April 21, 2020 | 0.1% |
Questions
Is there a generic for Cloderm?
Yes. The generic name for Cloderm is clocortolone pivalate. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Cloderm?
The active ingredient in Cloderm is clocortolone pivalate, 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.