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Efinaconazole

Efinaconazole · EFINACONAZOLE 1 g/g · Powder · Zhejiang Ausun Pharmaceutical Co., Ltd.

NDC 76397-0058-01 · 1000 g in 1 DRUM · BULK INGREDIENT · View full market →

Bulk ingredient — not a finished product

This NDC is a raw material (bulk ingredient) sold to drug manufacturers or compounders, not a product pharmacies dispense. Retail pricing, TE codes, fragility scores, and shortage reports don't apply to bulk listings — those attach to finished products made from this ingredient.

Medicare Part D

This is a bulk ingredient, not a dispensable product — it is a raw material sold to manufacturers and compounders, so no plan prices it.

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.

90-day shortage risk (model v2)

0.1%chance of a new FDA shortage posting for efinaconazole (other) in the next 90 days

sole-source market

For scale: the typical drug’s chance is about 0.1% — this one is in ordinary territory.

Backtested statistical model over the whole market, not this package alone. Model details →

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 $1,169.67 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
TE code
Approval date
Patents / exclusivity

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of Efinaconazole (Powder)

LabelerStrengthFirst seenLast seen
Zhejiang Ausun Pharmaceutical Co., Ltd.EFINACONAZOLE 1 g/gJul 15, 2026Sep 3, 2026
AX Pharmaceutical CorpEFINACONAZOLE 1 g/gJul 15, 2026Sep 2, 2026
Dipharma Francis SrlEFINACONAZOLE 1 kg/kgJul 15, 2026Sep 2, 2026
Harman Finochem LimitedEFINACONAZOLE 10 kg/10kgJul 15, 2026Sep 2, 2026
Maithri Drugs Private LimitedEFINACONAZOLE 1 kg/kgJul 15, 2026Sep 2, 2026
Matrix Pharmacorp Private LimitedEFINACONAZOLE 1 kg/kgJul 15, 2026Sep 2, 2026
Procos S.p.A.EFINACONAZOLE 50 kg/50kgJul 15, 2026Sep 2, 2026
Virupaksha Organics LimitedEFINACONAZOLE 1 kg/kgJul 15, 2026Sep 2, 2026
Viwit Pharmaceutical Co LtdEFINACONAZOLE 1 kg/kgJul 15, 2026Sep 2, 2026
Wavelength Enterprises LTDEFINACONAZOLE 1 kg/kgJul 15, 2026Sep 2, 2026
Zhejiang Ausun Pharmaceutical Co., Ltd.EFINACONAZOLE 1 kg/kgJul 15, 2026Aug 31, 2026

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

Cite this page

DrugDashboards, "Efinaconazole — NDC 76397-0058-01," retrieved September 3, 2026, https://drugdashboards.com/drug/76397005801.

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