DrugDashboards

Polocaine

Mepivacaine Hydrochloride · MEPIVACAINE HYDROCHLORIDE 30 mg/mL · Injection, Solution · Submucosal · Dentsply Pharmaceutical

NDC 66312-0441-16 · 50 CARTRIDGE in 1 CARTON / 1.7 mL in 1 CARTRIDGE · ANDA · View full market →

The short version

11 companies supply this market — deep enough that no single failure threatens the supply. A Class II recall hit this product in the past year (Novocol Pharmaceutical of Canada, Inc.).

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
ANDA088387
TE code
Approval date
Oct 10, 1984
Patents / exclusivity
None on file

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

  • Class II · OngoingOct 31, 2025
    Novocol Pharmaceutical of Canada, Inc.Defective container: cracked/broken cartridges

Manufacturers of Mepivacaine Hydrochloride (Injection, Solution)

LabelerStrengthFirst seenLast seen
Fresenius Kabi USA, LLCMEPIVACAINE HYDROCHLORIDE 20 mg/mLJul 15, 2026Sep 3, 2026
Benco DentalMEPIVACAINE HYDROCHLORIDE 30 mg/mLJul 15, 2026Sep 2, 2026
Darby Dental Supply, LLCMEPIVACAINE HYDROCHLORIDE 30 mg/mLJul 15, 2026Sep 2, 2026
Dentsply PharmaceuticalMEPIVACAINE HYDROCHLORIDE 30 mg/mLJul 15, 2026Sep 2, 2026
Fresenius Kabi USA, LLCMEPIVACAINE HYDROCHLORIDE 15 mg/mLJul 15, 2026Sep 2, 2026
Henry Schein Inc.MEPIVACAINE HYDROCHLORIDE 30 mg/mLJul 15, 2026Sep 2, 2026
NDC, Inc.MEPIVACAINE HYDROCHLORIDE 30 mg/mLJul 15, 2026Sep 2, 2026
Novocol Pharmaceutical of Canada Inc.MEPIVACAINE HYDROCHLORIDE 30 mg/mLJul 15, 2026Sep 2, 2026
Novocol Pharmaceutical of Canada, Inc.MEPIVACAINE HYDROCHLORIDE 30 mg/mLJul 15, 2026Sep 2, 2026
Patterson Dental Supply, Inc.MEPIVACAINE HYDROCHLORIDE 30 mg/mLJul 15, 2026Sep 2, 2026
Safco Dental Supply Co.MEPIVACAINE HYDROCHLORIDE 30 mg/mLJul 15, 2026Sep 2, 2026
Septodont, Inc.MEPIVACAINE HYDROCHLORIDE 30 mg/mLJul 15, 2026Sep 2, 2026
Fresenius Kabi USA, LLCMEPIVACAINE HYDROCHLORIDE 10 mg/mLJul 15, 2026Aug 31, 2026

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

Cite this page

DrugDashboards, "Polocaine — NDC 66312-0441-16," retrieved September 3, 2026, https://drugdashboards.com/drug/66312044116.

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