FDA Orange Book
Generic for Elimite
Elimite contains permethrin. 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 Elimite is permethrin. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Elimite products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| cream, topical | 5% | Marketed (Rx) | AB | 3 | AB |
NDA 019855, held by AUROBINDO PHARMA USA INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic permethrin
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| PADAGIS ISRAEL PHARMACEUTICALS LTD | 076369 | AB (A-rated, therapeutically equivalent) | April 21, 2003 | 5% |
| ENCUBE ETHICALS PVT LTD | 211303 | AB (A-rated, therapeutically equivalent) | April 3, 2019 | 5% |
| DR REDDYS LABORATORIES EU LTD | 209732 | AB (A-rated, therapeutically equivalent) | August 1, 2023 | 5% |
Elimite NDC codes
Questions
Is there a generic for Elimite?
Yes. The generic name for Elimite is permethrin. 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 Elimite?
The active ingredient in Elimite is permethrin, 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.