Does Anastrozole have a boxed warning?

No. None of the 39 FDA labels we found for this medicine has a boxed warning.

Is there a shortage of Anastrozole?

No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).

Has Anastrozole been recalled?

FDA enforcement reports list 4 recalls of products of this medicine; the newest started May 9, 2019 (Class II). A recall usually concerns specific lots, not every product.

Who makes Anastrozole?

23 companies list prescription products of Anastrozole in the FDA NDC Directory, including NuCare Pharmaceuticals, Inc., PD-Rx Pharmaceuticals, Inc. and Bryant Ranch Prepack.

Anastrozole (Arimidex): uses, warnings, recalls

Quick answers

What is Anastrozole used for?: The FDA-approved label (Arimidex, ANI Pharmaceuticals, Inc., March 2, 2026) says: “ARIMIDEX is an aromatase inhibitor indicated for: • Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer • First-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor-unknown locally advanced or metastatic breast cancer • Treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Anastrozole have a boxed warning?: No. None of the 39 FDA labels we found for this medicine has a boxed warning.
Is there a shortage of Anastrozole?: No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
Has Anastrozole been recalled?: FDA enforcement reports list 4 recalls of products of this medicine; the newest started May 9, 2019 (Class II). A recall usually concerns specific lots, not every product.
Who makes Anastrozole?: 23 companies list prescription products of Anastrozole in the FDA NDC Directory, including NuCare Pharmaceuticals, Inc., PD-Rx Pharmaceuticals, Inc. and Bryant Ranch Prepack.

What Anastrozole is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

ARIMIDEX is an aromatase inhibitor indicated for: • Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer • First-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor-unknown locally advanced or metastatic breast cancer • Treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy. …

— FDA label: Arimidex, ANI Pharmaceuticals, Inc., effective March 2, 2026. Read the full label on DailyMed →

The FDA has 39 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

Conditions named on the label

These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.

Breast cancer

Related medical specialties

Oncology

Boxed warning

A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.

The label quoted above has no boxed warning.

0 of 39 FDA labels for this medicine have a boxed warning.

Forms and how it is given

Dosage forms	Tablet · Tablet, coated · Tablet, film coated
Route	Oral
Prescription products	41 in the FDA NDC Directory
Brand names	Arimidex

What pharmacies pay (NADAC)

The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.

This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.

NADAC per unit for Anastrozole, by strength and form
Strength and form	Generic or brand	Pharmacies pay
anastrozole 1 mg tablet	Generic	$0.1485 per tablet
anastrozole 1 mg tablet	Brand: Arimidex	$52.89 per tablet
anastrozole 1 mg tablet, coated	Generic	$0.1485 per tablet
anastrozole 1 mg tablet, film coated	Generic	$0.1485 per tablet

NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.

Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →

Companies that list this medicine

Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.

NuCare Pharmaceuticals, Inc.9 products
PD-Rx Pharmaceuticals, Inc.4 products
Bryant Ranch Prepack3 products
Direct_Rx2 products
Asclemed USA, Inc.2 products
Proficient Rx LP2 products
AvKARE2 products
A-S Medication Solutions2 products
Chartwell RX, LLC1 product
Breckenridge Pharmaceutical, Inc.1 product
Aurobindo Pharma Limited1 product
American Health Packaging1 product
BluePoint Laboratories1 product
Yiling Pharmaceutical, Inc.1 product
Teva Pharmaceuticals USA, Inc.1 product
Natco Pharma Limited1 product
Zydus Lifesciences Limited1 product
Avet Pharmaceuticals Inc.1 product
Upsher-Smith Laboratories, LLC1 product
Zydus Pharmaceuticals USA Inc.1 product
Accord Healthcare Inc.1 product
ANI Pharmaceuticals, Inc.1 product
AvPAK1 product

FDA approval history

NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
ANDA: Abbreviated New Drug Application: how a generic version is approved.

Brand and biologic applications
Application	Sponsor	Approved	Later changes approved
NDA020541 ARIMIDEX	Ani Pharms	December 27, 1995	22, latest December 16, 2024 2024: Labeling · 2018: Labeling · 2014: Labeling

Generic approvals (6)

ANDA078058Teva Pharms · June 28, 2010
ANDA078921Zydus Pharms USA Inc · June 28, 2010
ANDA079220Natco Pharma Ltd · June 28, 2010
ANDA090568Accord Hlthcare · June 28, 2010
ANDA206037Pharmobedient · November 9, 2018
ANDA212434Eugia Pharma · July 24, 2020

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

Recalls

From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.

May 9, 2019 · Class II · Terminated · D-1467-2019

GMP Deviations: Potential cross contamination due to cleaning procedure failure.

Anastrozole Tablets, USP, 1 mg, a) 30-count (NDC 68001-155-04) and 1000-count (NDC 68001-155-08) bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India For BluePoint Laboratories — American Health Packaging
May 9, 2019 · Class II · Terminated · D-1394-2019

GMP Deviations: Potential cross contamination due to cleaning procedure failure.

Anastrozole Tablets, USP, 1mg, 30-count unit dose blisters per carton, Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC 60687-112-21. — American Health Packaging
May 6, 2019 · Class II · Terminated · D-1441-2019

CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.

Anastrozole Tablets, USP, 1 mg, 1,000-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534. NDC 68382-209-10 — Zydus Pharmaceuticals USA Inc
May 6, 2019 · Class II · Terminated · D-1440-2019

CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.

ANASTROZOLE Tablets, 1 mg, Rx Only, 30-count bottle, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India. Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534 NDC 68382-209-06 — Zydus Pharmaceuticals USA Inc

What do the recall classes mean?

Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).

Official identifiers

RxCUI (RxNorm)	151124, 199224
SPL set ID of the quoted label	acbfaaa9-503c-4691-9828-76a7146ed6de
FDA labels (SPL)	39
FDA applications	NDA020541, 6 ANDA
Active ingredients (FDA)	ANASTROZOLE

Sources

FDA-approved label on DailyMed (National Library of Medicine) — Arimidex, ANI Pharmaceuticals, Inc., effective March 2, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026

openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →

Report an error → · Information for medicine makers

Anastrozole

Official FDA data, not advice

At a glance