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.
Revonto
dantrolene sodium · DANTROLENE SODIUM 20 mg/60mL · Injection, Powder, Lyophilized, For Solution · Intravenous · Uswm, Llc
NDC 78670-0003-67 · 6 VIAL, GLASS in 1 CARTON / 60 mL in 1 VIAL, GLASS · 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.
Estimated fill cost
WAC per package, as filed
$420.00
Reported to Texas DSHS · 2026 annual filing · Uswm, Llc
Manufacturer list price as filed — not what pharmacies actually pay after discounts.
Supply fragility
Not scored — fragility is computed for NADAC-priced NDCs.
Where it's made
- Eurofins Biolab SrlItalyanalysis
- HAS Healthcare Advanced Synthesis SASwitzerlandapi manufacture
- Patheon Italia S.p.AItalyanalysis · label · manufacture · pack
- Patheon Manufacturing Services LLCUnited Statesanalysis · label · manufacture · pack
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 · avg $83.36 per prescription
- Biologic (BLA)
- Injectable / infused
- Orphan-drug exclusivity
- REMS program
Regulatory
- Application
- ANDA078378
- TE code
- AP
- Approval date
- Jul 24, 2007
- Patents / exclusivity
- None on file
Shortage history
No FDA shortage reports for this drug or its presentations.
Recalls (this NDC)
- Class II · TerminatedApr 13, 2022Mckesson Medical-Surgical Inc. Corporate Office — cGMP deviations: Temperature abuse
Manufacturers of dantrolene sodium (Injection, Powder, Lyophilized, For Solution)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| ProPharma Distribution | DANTROLENE SODIUM 20 mg/60mL | Jul 15, 2026 | Sep 2, 2026 |
| Uswm, Llc | DANTROLENE SODIUM 20 mg/60mL | Jul 15, 2026 | Sep 2, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Revonto — NDC 78670-0003-67," retrieved September 3, 2026, https://drugdashboards.com/drug/78670000367.
Free to cite with attribution — see how the data is put together.