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Articaine Hydrochloride and Epinephrine

Articaine Hydrochloride, Epinephrine Bitartrate · ARTICAINE HYDROCHLORIDE 40 mg/mL; EPINEPHRINE BITARTRATE 5 ug/mL · Injection, Solution · Submucosal · Burkhart Dental Supply Co., Inc

NDC 43498-0993-01 · 50 CARTRIDGE in 1 BOX / 1.8 mL in 1 CARTRIDGE · NDA AUTHORIZED GENERIC · View full market →

The short version

Only one company currently supplies this market — there is no backup if it stumbles.

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
NDA022466
TE code
Approval date
Feb 26, 2010
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 Articaine Hydrochloride, Epinephrine Bitartrate (Injection, Solution)

LabelerStrengthFirst seenLast seen
Burkhart Dental Supply Co., IncARTICAINE HYDROCHLORIDE 40 mg/mL; EPINEPHRINE BITARTRATE 10 ug/mLJul 15, 2026Sep 2, 2026
Burkhart Dental Supply Co., IncARTICAINE HYDROCHLORIDE 40 mg/mL; EPINEPHRINE BITARTRATE 5 ug/mLJul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Articaine Hydrochloride and Epinephrine — NDC 43498-0993-01," retrieved September 3, 2026, https://drugdashboards.com/drug/43498099301.

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