FDA Orange Book
Generic for Elidel
Elidel contains pimecrolimus. 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 Elidel is pimecrolimus. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Elidel products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| cream, topical | 1% | Marketed (Rx) | AB | 2 | AB |
NDA 021302, held by BAUSCH HEALTH US LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic pimecrolimus
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ACTAVIS LABORATORIES UT INC INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC | 209345 | AB (A-rated, therapeutically equivalent) | December 27, 2018 | 1% |
| GLENMARK PHARMACEUTICALS LTD | 211769 | AB (A-rated, therapeutically equivalent) | August 29, 2019 | 1% |
Elidel NDC codes
Questions
Is there a generic for Elidel?
Yes. The generic name for Elidel is pimecrolimus. 2 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 Elidel?
The active ingredient in Elidel is pimecrolimus, 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.