DrugDashboards

Zoledronic Acid

Zoledronic Acid · ZOLEDRONIC ACID 5 mg/100mL · Injection, Solution · Intravenous · Dr.Reddy's Laboratories Inc

NDC 43598-0331-11 · 100 mL in 1 BOTTLE, GLASS · ANDA · View full market →

The short version

10 companies supply this market — deep enough that no single failure threatens the supply. Historically, drugs in this position went on to a new shortage within 90 days about 0.4% of the time — roughly 2× the typical drug (0.1%).

The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.

Medicare Part D

No Medicare Part D plan in CMS's quarterly files lists this product. That usually means it is discontinued, a repackager's listing, or a product no plan has added to its formulary.

How Part D pricing works →

NADAC price per unit

$0$2.50$5.00$7.50Dec 2013Dec 2013$6.45
1 price point · per · last surveyed Invalid DateSource: CMS NADAC

Supply fragility

Not scored — fragility is computed for NADAC-priced NDCs.

90-day shortage risk (model v2)

0.4%chance of a new FDA shortage posting for zoledronic acid (injectable) in the next 90 days

sterile injectable · OAI inspection at a producing facility (24 months) · sole-source market

For scale: the typical drug’s chance is about 0.1% — this one is 2× that.

Backtested statistical model over the whole market, not this package alone. Model details →

Is this a "specialty" drug?

There's no legal definition — it meets 1 of 6 public criteria. Why that matters →

  • Part D specialty tier
  • Costs ≥ $950/fill · avg $154.07 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
ANDA091363
TE code
AP
Approval date
Mar 29, 2013
Patents / exclusivity
None on file

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

  • Class III · TerminatedSep 12, 2018
    Dr. Reddy's Laboratories, Inc. — Failed Impurities/Degradation Specifications: OOS for unknown impurities.

Manufacturers of Zoledronic Acid (Injection, Solution)

LabelerStrengthFirst seenLast seen
Mylan Institutional LLCZOLEDRONIC ACID 5 mg/100mLJul 15, 2026Sep 3, 2026
Sagent PharmaceuticalsZOLEDRONIC ACID .04 mg/mLJul 15, 2026Sep 3, 2026
Dr. Reddy's Laboratories IncZOLEDRONIC ACID 4 mg/100mLJul 15, 2026Sep 2, 2026
Dr.Reddy's Laboratories IncZOLEDRONIC ACID 5 mg/100mLJul 15, 2026Sep 2, 2026
Dr.Reddy's Laboratories LtdZOLEDRONIC ACID 5 mg/100mLJul 15, 2026Sep 2, 2026
Eugia US LLCZOLEDRONIC ACID 5 mg/100mLJul 15, 2026Sep 2, 2026
Fresenius Kabi USA, LLCZOLEDRONIC ACID 5 mg/100mLJul 15, 2026Sep 2, 2026
Gland Pharma LimitedZOLEDRONIC ACID .04 mg/mLJul 15, 2026Sep 2, 2026
Gland Pharma LimitedZOLEDRONIC ACID 5 mg/100mLJul 15, 2026Sep 2, 2026
Meitheal Pharmaceuticals Inc.ZOLEDRONIC ACID 5 mg/100mLJul 15, 2026Sep 2, 2026
Sagent PharmaceuticalsZOLEDRONIC ACID .05 mg/mLJul 15, 2026Sep 2, 2026
Sandoz IncZOLEDRONIC ACID 5 mg/100mLJul 15, 2026Sep 2, 2026

Roster from daily NDC Directory diffs — first/last seen dates start July 2026.

Cite this page

DrugDashboards, "Zoledronic Acid — NDC 43598-0331-11," retrieved September 3, 2026, https://drugdashboards.com/drug/43598033111.

Free to cite with attribution — see how the data is put together.