DrugDashboards

Vueway

Gadopiclenol · GADOPICLENOL 485.1 mg/mL · Injection · Intravenous · Bracco Diagnostics Inc

NDC 00270-7030-42 · 10 VIAL, SINGLE-DOSE in 1 CASE / 10 mL in 1 VIAL, SINGLE-DOSE · NDA · View full market →

The short version

Just 2 companies supply this market — thin enough that a single exit would be felt immediately. One of its named manufacturing plants, Liebel-Flarsheim Company LLC, failed FDA inspectionwithin the last two years — the agency’s most serious outcome.

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.

Medicare Part B (ASP)

Payment limit per 1 ML
$3.152
HCPCS A9573 · Jul 1, 2026 quarter · typically ASP + 6%

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
NDA216986
TE code
—
Approval date
Sep 21, 2022
Patents / exclusivity
27 patents, 14 exclusivities
TypeNumber / codeExpires
exclusivityNPPFeb 20, 2029
exclusivityNPPFeb 20, 2029
exclusivityNPPFeb 20, 2029
exclusivityNPPFeb 20, 2029
exclusivityNPPFeb 20, 2029
exclusivityNPPFeb 20, 2029
exclusivityNPPFeb 20, 2029
exclusivityNCESep 21, 2027
exclusivityNCESep 21, 2027
exclusivityNCESep 21, 2027
exclusivityNCESep 21, 2027
exclusivityNCESep 21, 2027

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of Gadopiclenol (Injection)

LabelerStrengthFirst seenLast seen
Bracco Diagnostics IncGADOPICLENOL 485.1 mg/mLJul 15, 2026Sep 3, 2026
Guerbet LLCGADOPICLENOL 485.1 mg/mLJul 15, 2026Sep 3, 2026

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

Cite this page

DrugDashboards, "Vueway — NDC 00270-7030-42," retrieved September 3, 2026, https://drugdashboards.com/drug/00270703042.

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