Active ingredient
Pimecrolimus
6 finished FDA listings contain Pimecrolimus as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- PIMECROLIMUS
- Dosage forms
- Cream
- Routes
- Topical
- Manufacturers / labelers
- 4
- Strengths listed
- 10 mg/g
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 321952
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 021302 | BAUSCH | 2001-12-13 | 4 |
| ANDA 209345 | ACTAVIS LABS UT INC | 2018-12-27 | 1 |
| ANDA 211769 | GLENMARK PHARMS LTD | 2019-08-29 | 1 |
Official labeling on DailyMed
- PIMECROLIMUS CREAM [OCEANSIDE PHARMACEUTICALS] · version 4 · 2026-05-21
- PIMECROLIMUS CREAM [GLENMARK PHARMACEUTICALS INC., USA] · version 3 · 2025-11-17
- PIMECROLIMUS CREAM [BRYANT RANCH PREPACK] · version 100 · 2025-11-17
- PIMECROLIMUS CREAM [ACTAVIS PHARMA, INC.] · version 5 · 2018-12-31
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.