DrugDashboards

Megatope

Iodinated I-131 Albumin · HUMAN SERUM ALBUMIN I-131 1 mCi/mL · Injection, Solution · Intravenous · Iso-Tex Diagnostics, Inc.

NDC 50914-7731-04 · 8 mL in 1 VIAL, MULTI-DOSE · BLA · 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, Iso-Tex Diagnostics, Inc., 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 2 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
BLA017837
TE code
Approval date
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 Iodinated I-131 Albumin (Injection, Solution)

LabelerStrengthFirst seenLast seen
Iso-Tex Diagnostics, Inc.HUMAN SERUM ALBUMIN I-131 .025 mCi/mLJul 15, 2026Sep 2, 2026
Iso-Tex Diagnostics, Inc.HUMAN SERUM ALBUMIN I-131 1 mCi/mLJul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Megatope — NDC 50914-7731-04," retrieved September 3, 2026, https://drugdashboards.com/drug/50914773104.

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