DrugDashboards

Procainamide Hydrochloride

Procainamide Hydrochloride · PROCAINAMIDE HYDROCHLORIDE 500 mg/mL · Injection, Solution · Intramuscular; Intravenous · Gland Pharma Limited

NDC 68083-0604-25 · 25 VIAL, MULTI-DOSE in 1 CASE / 2 mL in 1 VIAL, MULTI-DOSE · ANDA · View full market →

The short version

6 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
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
ANDA218135
TE code
AP
Approval date
Jul 22, 2024
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 Procainamide Hydrochloride (Injection, Solution)

LabelerStrengthFirst seenLast seen
Caplin Steriles LimitedPROCAINAMIDE HYDROCHLORIDE 500 mg/mLJul 15, 2026Sep 2, 2026
Caplin Steriles LimitedPROCAINAMIDE HYDROCHLORIDE 100 mg/mLJul 15, 2026Sep 2, 2026
Gland Pharma LimitedPROCAINAMIDE HYDROCHLORIDE 100 mg/mLJul 15, 2026Sep 2, 2026
Gland Pharma LimitedPROCAINAMIDE HYDROCHLORIDE 500 mg/mLJul 15, 2026Sep 2, 2026
Hospira, Inc.PROCAINAMIDE HYDROCHLORIDE 100 mg/mLJul 15, 2026Sep 2, 2026
Medical Purchasing Solutions, LLCPROCAINAMIDE HYDROCHLORIDE 100 mg/mLJul 15, 2026Sep 2, 2026
Medical Purchasing Solutions, LLC.PROCAINAMIDE HYDROCHLORIDE 100 mg/mLJul 15, 2026Sep 2, 2026
Sagent PharmaceuticalsPROCAINAMIDE HYDROCHLORIDE 100 mg/mLJul 15, 2026Sep 2, 2026
Sagent PharmaceuticalsPROCAINAMIDE HYDROCHLORIDE 500 mg/mLJul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Procainamide Hydrochloride — NDC 68083-0604-25," retrieved September 3, 2026, https://drugdashboards.com/drug/68083060425.

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