The short version
Just 2 companies supply this market — thin enough that a single exit would be felt immediately.
The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.
Articadent
Articaine hydrochloride and Epinephrine Bitartrate · ARTICAINE HYDROCHLORIDE 40 mg/mL; EPINEPHRINE BITARTRATE .005 mg/mL · Injection, Solution · Submucosal · Dentsply Pharmaceutical
NDC 66312-0602-16 · 50 CARTRIDGE in 1 CARTON / 1.7 mL in 1 CARTRIDGE · NDA AUTHORIZED GENERIC · View full market →
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
- manufacture
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
- NDA020971
- TE code
- —
- Approval date
- Apr 3, 2000
- Patents / exclusivity
- None on file
Shortage history
No FDA shortage reports for this drug or its presentations.
Recalls (this NDC)
- Class II · TerminatedMay 2, 2019Septodont Inc. — Labeling: Not Elsewhere Classified. This recall has been initiated due to mislabeling. The printed carton used in manufacturing both batches contained text for both 2% Xylocaine DENTAL and Articadent DENTAL. Xylocaine DENTAL is a trade name for Lidocaine HCL 2% and Epinephrine 1: 100,000 formulation, while Articadent DENTAL is a trade name for Articaine HCI 4% and Epinephrine 1 :100,000. The cartridges contained within the printed carton are labeled appropriately as Articadent DENTAL.
Manufacturers of Articaine hydrochloride and Epinephrine Bitartrate (Injection, Solution)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Dentsply Pharmaceutical | ARTICAINE HYDROCHLORIDE 40 mg/mL; EPINEPHRINE BITARTRATE .005 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
| Dentsply Pharmaceutical | ARTICAINE HYDROCHLORIDE 40 mg/mL; EPINEPHRINE BITARTRATE .01 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
| Septodont Inc. | ARTICAINE HYDROCHLORIDE 40 mg/mL; EPINEPHRINE BITARTRATE .005 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
| Septodont Inc. | ARTICAINE HYDROCHLORIDE 40 mg/mL; EPINEPHRINE BITARTRATE .01 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Articadent — NDC 66312-0602-16," retrieved September 3, 2026, https://drugdashboards.com/drug/66312060216.
Free to cite with attribution — see how the data is put together.