Pillstats
Rx only · Injection, Solution · Intravenous

Zoledronic Acid

Brands: Reclast · Zoledronic Acid

8 ACTIVE SUPPLIERS — US
openFDA · updated weekly
US13 NDCs
8 active makers
UKComing
soon
CAComing
soon
AUComing
soon
EUComing
soon
RxCUI (US)77655
US makers8 labelers
Packages16
DEA / ScheduleNone

US acquisition costNADAC · per unit

Average across 4 priced NDCs. A benchmark of pharmacy acquisition cost — not a retail quote.

$0.142$0.283$0.425$0.566Dec 2025Apr 2026Jul 2026
$0.492
Latest avg · Jul 22, 2026
+3%
Since Dec 17, 2025
8
Active US suppliers
50%
Top-2 supplier share*

Medicaid dispensing volumeSDUD · per quarter

Prescriptions dispensed under Medicaid (fee-for-service + managed care), summed nationally. The closest free proxy to sales volume — Medicaid only, not all-payer.

2.8K5.6K8.4K11K2025 Q12025 Q22025 Q32025 Q42026 Q1
5.6K
Rx · 2026 Q1
567K
Units dispensed
-37%
Rx vs. year ago
5
Quarters · since 2025 Q1

Who makes it8 active · 0 exited

US labelers as registered with FDA. Repackagers relabel another company's product; share* is of listed packages, not sales.

LabelerTypePackagesStatus
Sagent Pharmaceuticalsunknown5SUPPLYING
Dr.Reddy's laboratories Limitedunknown3SUPPLYING
Mylan Institutional LLCunknown2SUPPLYING
Gland Pharma Limitedunknown2SUPPLYING
Fresenius Kabi USA, LLCunknown1SUPPLYING
Eugia US LLCunknown1SUPPLYING
Meitheal Pharmaceuticals Inc.unknown1SUPPLYING
Sandoz Incunknown1SUPPLYING

Regulatory & supply eventsFDA · US

Shortages, recalls, and registration changes attached to this drug concept.

  • May 23, 2024
    RECALLRecall (Class II): Zoledronic Acid Injection 5mg/100mL Sterile Solution, 100mL Single-Dose vials, Rx only, Distributor: Dr. Reddy's Labora…

    Lack of Assurance of Sterility: Leaking vials — Recalling firm: Dr. Reddy's Laboratories, Inc. — Nationwide within the United States

  • Sep 12, 2018
    RECALLRecall (Class III): Zoledronic Acid Injection, 5mg/100 mL (0.05 mg/mL) 100ml vial, Rx Only. Mfd By: Gland Pharma Limited D.P. Pally - 500 0…

    Failed Impurities/Degradation Specifications: OOS for unknown impurities. — Recalling firm: Dr. Reddy's Laboratories, Inc. — Product was distributed to retailers, distributors, physician officers and medical facilities throughout the United Sta…

  • Sep 12, 2018
    RECALLRecall (Class III): Zoledronic Acid Injection, 5 mg/100 mL (0.05 mg/mL) One 100ml Single-Dose Bottle, Rx Only. NOVAPLUS Mfd By: Gland Pharm…

    Failed Impurities/Degradation Specifications: OOS for unknown impurities. — Recalling firm: Dr. Reddy's Laboratories, Inc. — Product was distributed to retailers, distributors, physician officers and medical facilities throughout the United Sta…

  • Mar 3, 2016
    RECALLRecall (Class II): Zoledronic Acid Injection, 5 mg/100 mL (0.05 mg/mL), 100 mL Single Use Bottle, Rx Only, Mfd. By: Gland Pharma Limited D…

    Lack of Assurance of Sterility; defective seals where the metal silver ring was not attached tightly to the vial — Recalling firm: Dr. Reddy's Laboratories, Inc. — Nationwide

  • Mar 4, 2014
    RECALLRecall (Class II): Zoledronic Acid Injection 5 mg per 100 mL (0.05 mg/mL), 100 mL single-use bag packaged in a foil overwrap, Rx only, Ste…

    Lack of Assurance of Sterility; leaking of premix bags — Recalling firm: Sagent Pharmaceuticals Inc — Nationwide