Quick answers
- What is Risedronate used for?
- The FDA-approved label (Risedronate Sodium, Teva Pharmaceuticals USA, Inc., March 30, 2026) says: “Risedronate sodium tablets are a bisphosphonate indicated for: Treatment and prevention of postmenopausal osteoporosis Treatment to increase bone mass in men with osteoporosis Treatment and prevention of glucocorticoid-induced osteoporosis Treatment of Paget’s disease Limitations of Use Optimal duration of use has not been determined. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Risedronate have a boxed warning?
- No. None of the 6 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Risedronate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Risedronate been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started March 10, 2022 (Class III). A recall usually concerns specific lots, not every product.
- Who makes Risedronate?
- 5 companies list prescription products of Risedronate in the FDA NDC Directory, including Aurobindo Pharma Limited, Macleods Pharmaceuticals Limited and Apotex Corp..
What Risedronate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Risedronate sodium tablets are a bisphosphonate indicated for: Treatment and prevention of postmenopausal osteoporosis Treatment to increase bone mass in men with osteoporosis Treatment and prevention of glucocorticoid-induced osteoporosis Treatment of Paget’s disease Limitations of Use Optimal duration of use has not been determined. …
— FDA label: Risedronate Sodium, Teva Pharmaceuticals USA, Inc., effective March 30, 2026. Read the full label on DailyMed →
The FDA has 6 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 6 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated |
|---|---|
| Route | Oral |
| Prescription products | 14 in the FDA NDC Directory |
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 |
|---|---|---|
| risedronate sodium 150 mg tablet, film coated | Generic | $11.02 per tablet |
| risedronate sodium 35 mg tablet, film coated | Generic | $1.47 per tablet |
| risedronate sodium 5 mg tablet, film coated | Generic | $1.52 per tablet |
| risedronate sodium monohydrate 35 mg tablet, film coated | Generic | $1.47 per tablet |
| risedronate sodium monohydrate 5 mg tablet, film coated | Generic | $1.52 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.
- Aurobindo Pharma Limited4 products
- Macleods Pharmaceuticals Limited3 products
- Apotex Corp.3 products
- Teva Pharmaceuticals USA, Inc.3 products
- Proficient Rx LP1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (5)
- ANDA077132Teva Pharms USA · October 5, 2007
- ANDA090877Apotex · June 10, 2014
- ANDA200296Aurobindo Pharma Ltd · November 30, 2015
- ANDA203533Macleods Pharms · December 9, 2015
- ANDA206768Aurobindo Pharma · October 21, 2016
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.
-
March 10, 2022 · Class III · Terminated · D-0762-2022
FAILED CONTENT UNIFORMITY SPECIFICATIONS
Risedronate Sodium Tablets, USP, 5 mg, Rx Only, 30-count bottle, Manufactured for: Macleods Pharma USA, Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., BAddi, HImchal Pradesh, INDIA, NDC 33342-107-0 — Macleods Pharma 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
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Risedronate Sodium, Teva Pharmaceuticals USA, Inc., effective March 30, 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 →