Active ingredient
Imiquimod
14 finished FDA listings contain Imiquimod as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- IMIQUIMOD
- Dosage forms
- Cream
- Routes
- Topical
- Manufacturers / labelers
- 9
- Strengths listed
- 12.5 mg/.25g · 2.5 mg/g · 37.5 mg/g · 50 mg/g
- Brand names in FDA listings
- Zyclara
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 59943
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 022483 | BAUSCH | 2010-03-25 | 5 |
| ANDA 078837 | PADAGIS ISRAEL | 2010-09-07 | 5 |
| ANDA 200173 | TARO | 2011-04-15 | 1 |
| ANDA 201994 | GLENMARK PHARMS | 2012-03-06 | 1 |
| ANDA 205971 | TARO | 2021-01-26 | 2 |
Official labeling on DailyMed
- ZYCLARA (IMIQUIMOD) CREAM [BAUSCH HEALTH US, LLC] · version 23 · 2026-02-16
- IMIQUIMOD CREAM [GLENMARK PHARMACEUTICALS INC., USA] · version 12 · 2026-01-26
- IMIQUIMOD CREAM [SUN PHARMACEUTICAL INDUSTRIES, INC.] · version 8 · 2026-01-26
- IMIQUIMOD CREAM [BRYANT RANCH PREPACK] · version 100 · 2025-11-17
- IMIQUIMOD CREAM [BRYANT RANCH PREPACK] · version 3 · 2025-09-29
- IMIQUIMOD CREAM [SUN PHARMACEUTICAL INDUSTRIES, INC.] · version 11 · 2025-08-13
- IMIQUIMOD CREAM [BRYANT RANCH PREPACK] · version 100 · 2025-08-01
- IMIQUIMOD CREAM [TEVA PHARMACEUTICALS USA, INC.] · version 5 · 2025-07-02
- IMIQUIMOD CREAM [OCEANSIDE PHARMACUETICALS] · version 7 · 2025-06-05
- IMIQUIMOD CREAM [DIRECT RX] · version 2 · 2025-01-20
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.