DrugDashboards

Acetazolamide

Acetazolamide · ACETAZOLAMIDE SODIUM 500 mg/5mL · Injection, Powder, Lyophilized, For Solution · Intravenous · Gland Pharma Limited

NDC 68083-0661-01 · 1 VIAL in 1 CARTON / 5 mL in 1 VIAL · ANDA · View full market →

The short version

4 companies supply this market — a reasonable cushion if one runs into trouble.

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

No NADAC pricing on file for this NDC — NADAC covers drugs dispensed by retail community pharmacies.

Supply fragility

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

Where it's made

Establishments this product's FDA label declares, located via FDA registration data. How we built this →

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 $43.36 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
ANDA219775
TE code
AP
Approval date
Jun 17, 2025
Patents / exclusivity
None on file

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of Acetazolamide (Injection, Powder, Lyophilized, For Solution)

LabelerStrengthFirst seenLast seen
Gland Pharma LimitedACETAZOLAMIDE SODIUM 500 mg/5mLJul 15, 2026Sep 2, 2026
XGen Pharmaceuticals DJB, Inc.ACETAZOLAMIDE SODIUM 500 mg/5mLJul 15, 2026Sep 2, 2026
Hikma Pharmaceuticals USA Inc.ACETAZOLAMIDE SODIUM 500 mg/1Jul 15, 2026Aug 31, 2026
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ACETAZOLAMIDE SODIUM 500 mg/5mLJul 15, 2026Aug 28, 2026

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

Cite this page

DrugDashboards, "Acetazolamide — NDC 68083-0661-01," retrieved September 3, 2026, https://drugdashboards.com/drug/68083066101.

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