Active ingredient
Exemestane
11 finished FDA listings contain Exemestane as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- EXEMESTANE
- Dosage forms
- Tablet, Tablet, Film Coated, Tablet, Sugar Coated
- Routes
- Oral
- Manufacturers / labelers
- 11
- Strengths listed
- 25 mg/1
- Brand names in FDA listings
- Aromasin
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 258494
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 020753 | PFIZER | 1999-10-21 | 2 |
| ANDA 209208 | UPSHER SMITH LABS | 2017-07-26 | 1 |
| ANDA 210323 | CIPLA | 2018-04-27 | 1 |
| ANDA 202602 | ZYDUS PHARMS | 2018-10-03 | 2 |
| ANDA 211031 | BRECKENRIDGE | 2019-02-21 | 2 |
| ANDA 213547 | QILU | 2020-04-13 | 1 |
| ANDA 216454 | EUGIA PHARMA | 2022-05-20 | 2 |
Official labeling on DailyMed
- AROMASIN (EXEMESTANE) TABLET [PHARMACIA & UPJOHN COMPANY LLC] · version 24 · 2025-12-25
- EXEMESTANE TABLET, SUGAR COATED [MYLAN PHARMACEUTICALS INC.] · version 20 · 2025-12-25
- EXEMESTANE TABLET, FILM COATED [FLORIDA PHARMACEUTICAL PRODUCTS, LLC] · version 5 · 2025-11-27
- EXEMESTANE TABLET, FILM COATED [NORTHSTAR RX LLC] · version 2 · 2025-08-06
- EXEMESTANE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] · version 2 · 2025-05-01
- EXEMESTANE TABLET [UPSHER-SMITH LABORATORIES, INC.] · version 8 · 2025-03-10
- EXEMESTANE TABLET [CIPLA USA INC.] · version 7 · 2025-01-21
- EXEMESTANE TABLET, FILM COATED [BRECKENRIDGE PHARMACEUTICAL, INC.] · version 10 · 2025-01-15
- EXEMESTANE TABLET [ZYDUS PHARMACEUTICALS USA INC.] · version 6 · 2025-01-03
- EXEMESTANE TABLET [ZYDUS LIFESCIENCES LIMITED] · version 6 · 2024-12-02
- EXEMESTANE TABLET, FILM COATED [BRYANT RANCH PREPACK] · version 104 · 2024-06-03
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.