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Dotarem

gadoterate meglumine · GADOTERATE MEGLUMINE 376.9 mg/mL · Injection · Intravenous · Guerbet LLC

NDC 67684-3001-02 · 10 SYRINGE, PLASTIC in 1 PACKAGE / 15 mL in 1 SYRINGE, PLASTIC · NDA · View full market →

The short version

Just 3 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.

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%)$0.0900per billing unit (0.1 ML)HCPCS A9575 · Jul 1, 2026
  • Federal contracts pay (FSS)$162.88per package of 10X15MLGuerbet L.L.C. · 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
$450.00
Reported to Texas DSHS · 2026 annual filing · Guerbet LLC

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

Medicare Part B (ASP)

Payment limit per 0.1 ML
$0.090
HCPCS A9575 · 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
NDA204781
TE code
AP
Approval date
Mar 20, 2013
Patents / exclusivity
None on file

Shortage history

  • Planned discontinuation Gadoterate Meglumine, Injection, 376.9 mg/1 mL (NDC 65219-080-05)May 21, 2026
  • Planned discontinuation Gadoterate Meglumine, Injection, 376.9 mg/1 mL (NDC 65219-082-10)May 21, 2026
  • Planned discontinuation Gadoterate Meglumine, Injection, 376.9 mg/1 mL (NDC 65219-084-15)May 21, 2026
  • Planned discontinuation Gadoterate Meglumine, Injection, 376.9 mg/1 mL (NDC 65219-086-20)May 21, 2026

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of gadoterate meglumine (Injection)

LabelerStrengthFirst seenLast seen
Fresenius Kabi USA, LLCGADOTERATE MEGLUMINE 376.9 mg/mLJul 15, 2026Sep 3, 2026
Guerbet LLCGADOTERATE MEGLUMINE 376.9 mg/mLJul 15, 2026Sep 3, 2026
Slate Run Pharmaceuticals, LLCGADOTERATE MEGLUMINE 376.9 mg/mLJul 15, 2026Aug 31, 2026

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

Cite this page

DrugDashboards, "Dotarem — NDC 67684-3001-02," retrieved September 3, 2026, https://drugdashboards.com/drug/67684300102.

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