Quick answers
- What is Raloxifene hydrochloride used for?
- The FDA-approved label (Evista, Eli Lilly and Company, February 11, 2026) says: “EVISTA ® is an estrogen agonist/antagonist indicated for: Treatment and prevention of osteoporosis in postmenopausal women. Reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis. Reduction in risk of invasive breast cancer in postmenopausal women at high risk for invasive breast cancer. Important Limitations …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Raloxifene hydrochloride have a boxed warning?
- Yes. The FDA label for Evista has a boxed warning (“WARNING: INCREASED RISK OF VENOUS THROMBOEMBOLISM AND DEATH FROM STROKE”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Raloxifene hydrochloride?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Raloxifene hydrochloride been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started December 4, 2019 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Raloxifene hydrochloride?
- 17 companies list prescription products of Raloxifene hydrochloride in the FDA NDC Directory, including Bryant Ranch Prepack, Aphena Pharma Solutions - Tennessee, LLC and A-S Medication Solutions.
What Raloxifene hydrochloride is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
EVISTA ® is an estrogen agonist/antagonist indicated for: Treatment and prevention of osteoporosis in postmenopausal women. Reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis. Reduction in risk of invasive breast cancer in postmenopausal women at high risk for invasive breast cancer. Important Limitations …
— FDA label: Evista, Eli Lilly and Company, effective February 11, 2026. Read the full label on DailyMed →
The FDA has 21 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.
This label has a boxed warning. Its heading: WARNING: INCREASED RISK OF VENOUS THROMBOEMBOLISM AND DEATH FROM STROKE
. Read it on the full label →
21 of 21 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated · Tablet, coated · Tablet |
|---|---|
| Route | Oral |
| Prescription products | 22 in the FDA NDC Directory |
| Brand names | Evista |
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 |
|---|---|---|
| raloxifene hydrochloride 60 mg tablet | Generic | $0.2205 per tablet |
| raloxifene hydrochloride 60 mg tablet | Brand: Evista | $6.34 per tablet |
| raloxifene hydrochloride 60 mg tablet, coated | Generic | $0.2205 per tablet |
| raloxifene hydrochloride 60 mg tablet, film coated | Generic | $0.2205 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.
- Bryant Ranch Prepack4 products
- Aphena Pharma Solutions - Tennessee, LLC2 products
- A-S Medication Solutions2 products
- Modavar Pharmaceuticals LLC1 product
- Amneal Pharmaceuticals LLC1 product
- Aurobindo Pharma Limited1 product
- Teva Pharmaceuticals USA, Inc.1 product
- AvPAK1 product
- American Health Packaging1 product
- Dr.Reddys Laboratories Inc1 product
- Exelan Pharmaceuticals Inc.1 product
- Major Pharmaceuticals1 product
- NorthStar Rx LLC1 product
- Cipla USA Inc.1 product
- ScieGen Pharmaceuticals, Inc.1 product
- Eli Lilly and Company1 product
- Cadila Pharmaceuticals Limited1 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 |
|---|---|---|---|
| NDA020815 EVISTA | Lilly | December 9, 1997 | 17, latest June 27, 2018 2018: Labeling · 2016: Manufacturing (CMC) · 2016: Manufacturing (CMC) |
Generic approvals (6)
- ANDA078193Teva Pharms USA · March 4, 2014
- ANDA090842Invagen Pharms · September 24, 2014
- ANDA204310Aurobindo Pharma · August 28, 2015
- ANDA208206Amneal Pharms · April 8, 2016
- ANDA206384Sciegen Pharms · October 12, 2016
- ANDA211324Cadila Pharms Ltd · August 18, 2020
Shortage status
The FDA drug shortage list does not show these products.
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.
-
December 4, 2019 · Class II · Terminated · D-0854-2020
Failed Dissolution Specifications: Low out of specification results obtained during stability testing.
Raloxifene Hydrochloride Tablets, USP, 60 mg, 30 Tablets (3 x 10 blister cards), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC carton: 60687-266-21; NDC Unit Dose: 60687-266-1 — American Health Packaging
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) | 1490065, 1490067 |
|---|---|
| SPL set ID of the quoted label | fcaaa6dc-74e8-4fb8-800c-5574bf0f8de9 |
| FDA labels (SPL) | 21 |
| FDA applications | NDA020815, 6 ANDA |
| Active ingredients (FDA) | RALOXIFENE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Evista, Eli Lilly and Company, effective February 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 →