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Vistaseal

human fibrinogen, human thrombin · Kit · Grifols Usa, Llc

NDC 61953-0011-01 · 1 KIT in 1 PACKAGE, COMBINATION * 1 mL in 1 SYRINGE, GLASS * 1 mL in 1 SYRINGE, GLASS · BLA · 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 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
BLA125640
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 human fibrinogen, human thrombin (Kit)

LabelerStrengthFirst seenLast seen
Grifols Usa, LlcJul 15, 2026Aug 31, 2026

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

Cite this page

DrugDashboards, "Vistaseal — NDC 61953-0011-01," retrieved September 3, 2026, https://drugdashboards.com/drug/61953001101.

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