Quick answers
- What is Letrozole used for?
- The FDA-approved label (Femara, Novartis Pharmaceuticals Corporation, June 11, 2026) says: “Femara is an aromatase inhibitor indicated for: Adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer. Extended adjuvant treatment of postmenopausal women with early breast cancer who have received prior standard adjuvant tamoxifen therapy. First and second-line treatment of postmenopausal women with hormone receptor positive or unknown advanced breast cancer. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Letrozole have a boxed warning?
- No. None of the 24 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Letrozole?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Letrozole been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Letrozole?
- 20 companies list prescription products of Letrozole in the FDA NDC Directory, including Bryant Ranch Prepack, A-S Medication Solutions and NuCare Pharmaceuticals, Inc..
What Letrozole is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Femara is an aromatase inhibitor indicated for: Adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer. Extended adjuvant treatment of postmenopausal women with early breast cancer who have received prior standard adjuvant tamoxifen therapy. First and second-line treatment of postmenopausal women with hormone receptor positive or unknown advanced breast cancer. …
— FDA label: Femara, Novartis Pharmaceuticals Corporation, effective June 11, 2026. Read the full label on DailyMed →
The FDA has 24 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.
Related medical specialties
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 24 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated · Tablet |
|---|---|
| Route | Oral |
| Prescription products | 24 in the FDA NDC Directory |
| Brand names | Femara |
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.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| letrozole 2.5 mg tablet | Generic | $0.1502 per tablet |
| letrozole 2.5 mg tablet, film coated | Generic | $0.1502 per tablet |
| letrozole 2.5 mg tablet, film coated | Brand: Femara | $27.12 per tablet |
NADAC list of November 4, 2026; these prices took effect between January 7, 2026 and 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.
- Bryant Ranch Prepack3 products
- A-S Medication Solutions2 products
- NuCare Pharmaceuticals, Inc.2 products
- AvPAK1 product
- Golden State Medical Supply, Inc.1 product
- Teva Pharmaceuticals USA, Inc.1 product
- Breckenridge Pharmaceutical, Inc.1 product
- Chartwell RX, LLC1 product
- Natco Pharma Limited1 product
- Novartis Pharmaceuticals Corporation1 product
- Atlantic Biologicals Corp.1 product
- Aurobindo Pharma Limited1 product
- AvKARE1 product
- Proficient Rx LP1 product
- Carnegie Pharmaceuticals LLC1 product
- Upsher-Smith Laboratories, LLC1 product
- Accord Healthcare Inc.1 product
- Avet Pharmaceuticals Inc.1 product
- Dr. Reddy's Laboratories Limited1 product
- Yiling Pharmaceutical, Inc.1 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.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA020726 FEMARA | Novartis Pharms | July 25, 1997 | 26, latest December 16, 2024 2024: Labeling · 2018: Labeling · 2017: Labeling |
Generic approvals (6)
- ANDA090289Teva Pharms · June 3, 2011
- ANDA090934Accord Hlthcare · June 3, 2011
- ANDA091191Pharmobedient · June 3, 2011
- ANDA200161Natco Pharma Ltd · June 3, 2011
- ANDA205869Pharmobedient · November 14, 2018
- ANDA211717Eugia Pharma · January 11, 2019
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 153124, 200064 |
|---|---|
| SPL set ID of the quoted label | 82b77d74-085f-45ac-a7dd-1f5c038bf406 |
| FDA labels (SPL) | 24 |
| FDA applications | NDA020726, 6 ANDA |
| Active ingredients (FDA) | LETROZOLE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Femara, Novartis Pharmaceuticals Corporation, effective June 11, 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 →