FDA Orange Book
Generic for Aldara
Aldara contains imiquimod. 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 Aldara is imiquimod. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
Run it in Rivvi
Map Aldara 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.
Aldara products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| cream, topical | 5% | Discontinued | None | 4 | AB |
NDA 020723, 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 imiquimod
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| FOUGERA PHARMACEUTICALS INC | 078548 | AB (A-rated, therapeutically equivalent) | February 25, 2010 | 5% |
| PADAGIS ISRAEL PHARMACEUTICALS LTD | 078837 | AB (A-rated, therapeutically equivalent) | September 7, 2010 | 5% |
| TARO PHARMACEUTICAL INDUSTRIES LTD | 200173 | AB (A-rated, therapeutically equivalent) | April 15, 2011 | 5% |
| GLENMARK PHARMACEUTICALS INC USA | 201994 | AB (A-rated, therapeutically equivalent) | March 6, 2012 | 5% |
Questions
Is there a generic for Aldara?
Yes. The generic name for Aldara is imiquimod. 4 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 Aldara?
The active ingredient in Aldara is imiquimod, 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.