DrugDashboards

Gadavist

gadobutrol · GADOBUTROL 604.72 mg/mL · Injection · Intravenous · Bayer HealthCare Pharmaceuticals Inc.

NDC 50419-0325-18 · 2 CARTON in 1 BOX / 5 BOTTLE, GLASS in 1 CARTON / 30 mL in 1 BOTTLE, GLASS · NDA · View full market →

The short version

5 companies supply this market — a reasonable cushion if one runs into trouble.

The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.

One drug, every price

The same NDC has different prices depending on who is paying. Units differ between rungs — compare within a rung over time, not rung against rung, unless the units match.

ⓘ How this was built
Data sources
  • CMS NADAC (pharmacy acquisition, weekly)
  • CMS Part B ASP quarterly payment limits
  • CMS Maximum Fair Prices (IRA negotiated, NDC-level)
  • Medicare Part D Spending by Drug (data.cms.gov, name-matched)
  • VA FSS / Big4 federal contract prices (va.gov, twice monthly)
  • ACA Federal Upper Limits + weighted AMP (data.medicaid.gov, monthly)
  • California SB-17 WAC filings (list price, per package)
Method

Each rung is the newest figure for this NDC from one federal price system, shown with its own unit. Part D is matched by drug name because CMS publishes no NDCs there; it is gross spending, before confidential rebates.

Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.

  • Medicare Part B pays (ASP+6%)$0.2620per billing unit (0.1 ML)HCPCS A9585 · Jul 1, 2026
  • Federal ceiling (Big4)$477.07per package of 10X30MLBayer HealthCare Pharmaceuticals, Inc. · Jan 1, 2026

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.

Estimated fill cost

WAC per package, as filed
$249.00
Reported to Texas DSHS · 2026 annual filing · Bayer Healthcare Pharmaceuticals, Inc

Manufacturer list price as filed — not what pharmacies actually pay after discounts.

Medicare Part B (ASP)

Payment limit per 0.1 ML
$0.262
HCPCS A9585 · Jul 1, 2026 quarter · typically ASP + 6%

Medicaid spend (2025)

$126,649
5,290 prescriptions paid by Medicaid nationally · all Medicaid spend →

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
NDA201277
TE code
AP
Approval date
Mar 14, 2011
Patents / exclusivity
None on file

Shortage history

  • Planned discontinuation Gadobutrol, Injection, 604.72 mg/mL (NDC 65219-281-02)Jun 30, 2026
  • Planned discontinuation Gadobutrol, Injection, 604.72 mg/mL (NDC 65219-281-07)Jun 30, 2026
  • Planned discontinuation Gadobutrol, Injection, 604.72 mg/mL (NDC 65219-281-10)Jun 30, 2026
  • Planned discontinuation Gadobutrol, Injection, 604.72 mg/mL (NDC 65219-281-15)Jun 30, 2026

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of gadobutrol (Injection)

LabelerStrengthFirst seenLast seen
Slate Run Pharmaceuticals, LLCGADOBUTROL 604.72 mg/mLJul 15, 2026Sep 3, 2026
Zydus Pharmaceuticals USA Inc.GADOBUTROL 604.72 mg/mLJul 25, 2026Sep 3, 2026
Fresenius Kabi USA, LLCGADOBUTROL 604.72 mg/mLJul 15, 2026Aug 31, 2026
Viwit Pharmaceutical Co., Ltd.GADOBUTROL 604.72 mg/mLJul 25, 2026Aug 31, 2026
Bayer HealthCare Pharmaceuticals Inc.GADOBUTROL 604.72 mg/mLJul 15, 2026Aug 28, 2026

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

Cite this page

DrugDashboards, "Gadavist — NDC 50419-0325-18," retrieved September 3, 2026, https://drugdashboards.com/drug/50419032518.

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