Quick answers
- What is Alendronate sodium used for?
- The FDA-approved label (Fosamax, Organon LLC, March 12, 2026) says: “FOSAMAX is a bisphosphonate indicated for: Treatment and prevention of osteoporosis in postmenopausal women ( 1.1, 1.2 ) Treatment to increase bone mass in men with osteoporosis Treatment of glucocorticoid-induced osteoporosis Treatment of Paget's disease of bone 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 Alendronate sodium have a boxed warning?
- No. None of the 21 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Alendronate sodium?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Alendronate sodium been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started April 7, 2026 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Alendronate sodium?
- 17 companies list prescription products of Alendronate sodium in the FDA NDC Directory, including Amneal Pharmaceuticals of New York LLC, A-S Medication Solutions and NorthStar Rx LLC.
What Alendronate sodium is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
FOSAMAX is a bisphosphonate indicated for: Treatment and prevention of osteoporosis in postmenopausal women ( 1.1, 1.2 ) Treatment to increase bone mass in men with osteoporosis Treatment of glucocorticoid-induced osteoporosis Treatment of Paget's disease of bone Limitations of use: Optimal duration of use has not been determined. …
— FDA label: Fosamax, Organon LLC, effective March 12, 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.
The label quoted above has no boxed warning.
0 of 21 FDA labels for this medicine have a boxed warning.
Forms and how it is given
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 |
|---|---|---|
| alendronate sodium 10 mg tablet | Generic | $0.1174 per tablet |
| alendronate sodium 35 mg tablet | Generic | $0.2845 per tablet |
| alendronate sodium 70 mg tablet | Generic | $0.2571 per tablet |
| alendronate sodium 70 mg tablet | Brand: Fosamax | $38.70 per tablet |
| alendronate sodium 70 mg/75 mL solution | Generic | $0.6904 per mL |
| alendronate sodium 91.37 mg tablet, effervescent | Brand: Binosto | $71.23 per tablet |
NADAC list of November 4, 2026; these prices took effect between January 1, 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.
- Amneal Pharmaceuticals of New York LLC5 products
- A-S Medication Solutions4 products
- NorthStar Rx LLC3 products
- Aurobindo Pharma Limited3 products
- Rising Pharma Holdings, Inc.3 products
- Marlex Pharmaceuticals, Inc.2 products
- Cipla USA Inc.2 products
- Remedyrepack Inc.2 products
- Hangzhou Minsheng Binjiang Pharmaceutical Co., Ltd.2 products
- NuCare Pharmaceuticals, Inc.2 products
- Exelan Pharmaceuticals Inc.2 products
- Radius Health, Inc.1 product
- Preferred Pharmaceuticals Inc.1 product
- Proficient Rx LP1 product
- ANI Pharmaceuticals, Inc.1 product
- Organon LLC1 product
- Hikma Pharmaceuticals USA 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 |
|---|---|---|---|
| NDA020560 FOSAMAX | Organon | September 29, 1995 | 53, latest February 3, 2026 2026: Labeling · 2019: Labeling · 2015: Labeling |
| NDA202344 BINOSTO | Radius | March 12, 2012 | 12, latest February 3, 2026 2026: Labeling · 2020: Labeling · 2020: Labeling |
Generic approvals (6)
- ANDA075710Impax Labs Inc · February 6, 2008
- ANDA076768Cipla · August 4, 2008
- ANDA090124Aurobindo Pharma · August 4, 2008
- ANDA090258Hangzhou Binjiang · September 24, 2009
- ANDA090520Hikma · February 25, 2013
- ANDA214512Novitium Pharma · May 11, 2023
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.
-
April 7, 2026 · Class II · Ongoing · D-0526-2026
This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side.
Alendronate Sodium Oral Solution, 70 mg/75 mL, 75 mL, Rx only, 4 x 75 mL Single Dose Bottles, Distr. by: Hikma Pharmaceuticals USA Inc., Berkeley Heights, NJ 07922, NDC 0054-0282-59. — Hikma 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
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Fosamax, Organon LLC, effective March 12, 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 →