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Data / Drug companies / Zoledronic acid

Zoledronic acid: 18 companies and 35 products in the FDA NDC directory

Zoledronic acid is listed in the FDA National Drug Code Directory by 18 companies, with 35 products in commercial distribution. 32 of the products (91.4%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are injection, solution, concentrate; injection, solution; injection, and the newest product started marketing on February 5, 2026.

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Companies listing it
18
Products
35
Generic (ANDA) products
32 (91.4%)
Application numbers
22
Routes
Intravenous
Brand names
Reclast
openFDA record search
api.fda.gov

Companies that list zoledronic acid

Ranked by number of products. Finished drugs in commercial distribution.

CompanyProductsMain dosage formsMain marketing categoryNewest product started
Gland Pharma Limited6injection; injection, solution, concentrateGeneric drugs (ANDA)February 5, 2026
Dr. Reddy's Laboratories Inc.4injection, solution, concentrate; injection, solutionGeneric drugs (ANDA)August 21, 2023
Mylan Institutional LLC3injection, solution; injection, solution, concentrateGeneric drugs (ANDA)June 5, 2018
Sagent Pharmaceuticals3injection, solutionNew drug applications (NDA)September 1, 2015
BluePoint Laboratories2injection; injection, solution, concentrateGeneric drugs (ANDA)March 8, 2024
Bpi Labs LLC2injection, solution, concentrateGeneric drugs (ANDA)June 5, 2025
Dr. Reddy's Laboratories Limited2injection, solution, concentrate; injection, solutionGeneric drugs (ANDA)April 3, 2013
Eugia US LLC2injection, solution; injection, solution, concentrateGeneric drugs (ANDA)December 8, 2017
Fresenius Kabi USA, LLC2injection; injection, solutionGeneric drugs (ANDA)February 17, 2017
Accord Healthcare Inc.1injectionGeneric drugs (ANDA)October 16, 2017
Avenacy, LLC1injection, solution, concentrateGeneric drugs (ANDA)January 15, 2025
Fosun Pharma USA Inc.1injectionGeneric drugs (ANDA)June 12, 2023
Heritage Pharmaceuticals Inc. D/B/A Avet Pharmaceuticals Inc.1injection, solution, concentrateGeneric drugs (ANDA)August 31, 2023
Hikma Pharmaceuticals USA Inc.1injection, solution, concentrateGeneric drugs (ANDA)June 3, 2013
Meitheal Pharmaceuticals Inc.1injection, solutionGeneric drugs (ANDA)June 5, 2023
NorthStar RxLLC1injection, solution, concentrateGeneric drugs (ANDA)November 1, 2023
Sandoz Inc1injection, solutionNew drug applications (NDA)April 1, 2007
Westminster Pharmaceuticals, LLC1injectionGeneric drugs (ANDA)February 2, 2023

Dosage forms

Dosage formProductsShare
Injection, solution, concentrate1440%
Injection, solution1440%
Injection720%

Marketing categories

Marketing categoryProductsShare
Generic drugs (ANDA)3291.4%
New drug applications (NDA)38.6%

Pharmacologic classes

ClassProducts
Bisphosphonate35

Updated November 6, 2026. Read from US Food and Drug Administration, National Drug Code Directory (openFDA). CC0 1.0 public domain dedication (openFDA). Counts are products in the FDA National Drug Code Directory on November 6, 2026: 138,262 products in commercial distribution, meaning without a marketing end date in the past. A company is a labeler code; one company can hold several codes, and the directory carries no address. Inclusion in the directory is not FDA approval, and the marketing category says under which kind of application or rule a product is sold. This page uses openFDA data and is not endorsed or certified by FDA. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.