Active ingredient
Anastrozole
40 finished FDA listings contain Anastrozole as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- ANASTROZOLE
- Dosage forms
- Tablet, Tablet, Coated, Tablet, Film Coated
- Routes
- Oral
- Manufacturers / labelers
- 25
- Strengths listed
- 1 mg/1
- Brand names in FDA listings
- Anastrozole, Arimidex
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 84857
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 020541 | ANI PHARMS | 1995-12-27 | 1 |
| ANDA 079220 | NATCO PHARMA LTD | 2010-06-28 | 10 |
| ANDA 090568 | ACCORD HLTHCARE | 2010-06-28 | 11 |
| ANDA 078058 | TEVA PHARMS | 2010-06-28 | 2 |
| ANDA 078921 | ZYDUS PHARMS USA INC | 2010-06-28 | 6 |
| ANDA 206037 | BEIJING YILING | 2018-11-09 | 8 |
| ANDA 212434 | EUGIA PHARMA | 2020-07-24 | 2 |
Official labeling on DailyMed
- ANASTROZOLE TABLET [BRYANT RANCH PREPACK] · version 105 · 2026-08-21
- ANASTROZOLE TABLET [BRECKENRIDGE PHARMACEUTICAL, INC.] · version 14 · 2026-08-20
- ANASTROZOLE TABLET [PD-RX PHARMACEUTICALS, INC.] · version 17 · 2026-08-10
- ANASTROZOLE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] · version 2 · 2026-08-07
- ANASTROZOLE TABLET [DIRECT_RX] · version 1 · 2026-08-06
- ANASTROZOLE TABLET [PD-RX PHARMACEUTICALS, INC.] · version 18 · 2026-07-08
- ANASTROZOLE TABLET, COATED [BRYANT RANCH PREPACK] · version 1 · 2026-06-22
- ANASTROZOLE (ANASTROZOLE TABLETS) TABLET [ASCLEMED USA INC.] · version 1 · 2026-06-17
- ANASTROZOLE TABLET [NUCARE PHARMACEUTICALS,INC.] · version 3 · 2026-06-11
- ANASTROZOLE (ANASTROZOLE TABLETS) TABLET [NUCARE PHARMACEUTICALS, INC.] · version 1 · 2026-05-11
- ANASTROZOLE TABLET [AVPAK] · version 5 · 2026-03-12
- ARIMIDEX (ANASTROZOLE) TABLET [ANI PHARMACEUTICALS, INC.] · version 12 · 2026-03-05
Showing the 12 most recent of 40 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.