Fomepizole

Fomepizole · FOMEPIZOLE 1.5 g/1.5mL · Injection · Intravenous · Sagent Pharmaceuticals

NDC 25021-0829-02 · 1 VIAL in 1 CARTON / 1.5 mL in 1 VIAL · ANDA · View full market →

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.

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

$985.00

Reported to Texas DSHS · 2026 annual filing · Sagent Pharmaceuticals

Manufacturer list price as filed — not what pharmacies actually pay after discounts.

Supply fragility

Not scored — fragility is computed for NADAC-priced NDCs.

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: ANDA216791
TE code: AP
Approval date: Jul 6, 2023
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 Fomepizole (Injection)

Labeler	Strength	First seen	Last seen
Gland Pharma Limited	FOMEPIZOLE 1 g/mL	Jul 15, 2026	Sep 2, 2026
Sagent Pharmaceuticals	FOMEPIZOLE 1.5 g/1.5mL	Jul 15, 2026	Sep 2, 2026

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

Cite this page

DrugDashboards, "Fomepizole — NDC 25021-0829-02," retrieved September 3, 2026, https://drugdashboards.com/drug/25021082902.

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