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.
Citanest Forte DENTAL
prilocaine hcl and epinephrine · PRILOCAINE HYDROCHLORIDE 40 mg/mL; EPINEPHRINE BITARTRATE .005 mg/mL · Injection, Solution · Submucosal · Dentsply Pharmaceutical Inc.
NDC 66312-0580-16 · 50 CARTRIDGE in 1 CARTON / 1.8 mL in 1 CARTRIDGE · ANDA · 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
- ANDA078959
- TE code
- AP
- Approval date
- Aug 30, 2011
- 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 prilocaine hcl and epinephrine (Injection, Solution)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Dentsply Pharmaceutical Inc. | PRILOCAINE HYDROCHLORIDE 40 mg/mL; EPINEPHRINE BITARTRATE .005 mg/mL | Aug 26, 2026 | Sep 2, 2026 |
| Novocol Pharmaceutical of Canada, Inc. | PRILOCAINE HYDROCHLORIDE 40 mg/mL; EPINEPHRINE BITARTRATE .005 mg/mL | Aug 26, 2026 | Sep 2, 2026 |
| Dentsply Pharmaceutical Inc. | PRILOCAINE HYDROCHLORIDE .005 mg/mL; EPINEPHRINE BITARTRATE 40 mg/mL | Jul 22, 2026 | Aug 19, 2026 |
| Novocol Pharmaceutical of Canada, Inc. | PRILOCAINE HYDROCHLORIDE .005 mg/mL; EPINEPHRINE BITARTRATE 40 mg/mL | Jul 22, 2026 | Aug 19, 2026 |
| Dentsply Pharmaceutical Inc. | EPINEPHRINE BITARTRATE .005 mg/mL; PRILOCAINE HYDROCHLORIDE 40 mg/mL | Jul 15, 2026 | Jul 15, 2026 |
| Novocol Pharmaceutical of Canada, Inc. | EPINEPHRINE BITARTRATE .005 mg/mL; PRILOCAINE HYDROCHLORIDE 40 mg/mL | Jul 15, 2026 | Jul 15, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Citanest Forte DENTAL — NDC 66312-0580-16," retrieved September 3, 2026, https://drugdashboards.com/drug/66312058016.
Free to cite with attribution — see how the data is put together.