DrugDashboards

Drax Exametazime

Kit for the Preparation of Technetium Tc 99m Exametazime for Leukocyte Labeling · TECHNETIUM TC-99M EXAMETAZIME .5 mg/1 · Injection, Powder, Lyophilized, For Solution · Intravenous · Jubilant DraxImage Inc., dba Jubilant Radiopharma

NDC 65174-0200-05 · 5 VIAL in 1 CARTON / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL · NDA · View full market →

The short version

Only one company currently supplies this market — there is no backup if it stumbles. One of its named manufacturing plants, Jubilant HollisterStier General Partnership, failed FDA inspectionwithin the last two years — the agency’s most serious outcome.

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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

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
NDA208870
TE code
Approval date
Aug 17, 2017
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 Kit for the Preparation of Technetium Tc 99m Exametazime for Leukocyte Labeling (Injection, Powder, Lyophilized, For Solution)

LabelerStrengthFirst seenLast seen
Jubilant DraxImage Inc., dba Jubilant RadiopharmaTECHNETIUM TC-99M EXAMETAZIME .5 mg/1Jul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Drax Exametazime — NDC 65174-0200-05," retrieved September 3, 2026, https://drugdashboards.com/drug/65174020005.

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