Zycubo

copper histidinate · COPPER HISTIDINATE 2.9 mg/1 · Injection, Powder, Lyophilized, For Solution · Subcutaneous · Sentynl Therapeutics, Inc.

NDC 42358-0329-01 · 1 VIAL, GLASS in 1 CARTON / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS · NDA · View full market →

The short version

Only one company currently supplies this market — there is no backup if it stumbles.

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.

Supply fragility

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

Is this a "specialty" drug?

There's no legal definition — it meets 3 of 6 public criteria. Why that matters →

Part D specialty tier
Costs ≥ $950/fill
Biologic (BLA)
Injectable / infused
Orphan-drug exclusivity
REMS program · Miudella

Regulatory

Application: NDA211241
TE code: —
Approval date: Jan 12, 2026
Patents / exclusivity: 0 patents, 2 exclusivities

Type	Number / code	Expires
exclusivity	ODE-520	Jan 12, 2033
exclusivity	NCE	Jan 12, 2031

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of copper histidinate (Injection, Powder, Lyophilized, For Solution)

Labeler	Strength	First seen	Last seen
Sentynl Therapeutics, Inc.	COPPER HISTIDINATE 2.9 mg/1	Jul 15, 2026	Sep 2, 2026

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

Cite this page

DrugDashboards, "Zycubo — NDC 42358-0329-01," retrieved September 3, 2026, https://drugdashboards.com/drug/42358032901.

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