DrugDashboards

Osmitrol

Mannitol · MANNITOL 20 g/100mL · Injection, Solution · Intravenous · Baxter Healthcare Company

NDC 00338-0357-03 · 500 mL in 1 BAG · NDA · View full market →

The short version

8 companies supply this market — a reasonable cushion if one runs into trouble. One of its named manufacturing plants, Baxter Healthcare Corporation, 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.

  • Part D plans paid (avg)$0.0557per dosage unitgross, before rebates — matched by drug name · 2024
  • Federal contracts pay (FSS)$409.68per package of 24X500MLBaxter Healthcare Corporation · Sep 17, 2025

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
$63.06
Reported to Texas DSHS · 2026 annual filing · Baxter Healthcare Corporation

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

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 · avg $1,904.63 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
NDA013684
TE code
AP
Approval date
Jan 1, 1982
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 Mannitol (Injection, Solution)

LabelerStrengthFirst seenLast seen
B. Braun Medical Inc.MANNITOL 20 g/100mLJul 15, 2026Sep 2, 2026
Baxter Healthcare CompanyMANNITOL 10 g/100mLJul 15, 2026Sep 2, 2026
Baxter Healthcare CompanyMANNITOL 20 g/100mLJul 15, 2026Sep 2, 2026
Fresenius Kabi USA, LLCMANNITOL 250 mg/mLJul 15, 2026Sep 2, 2026
Henry Schein, Inc.MANNITOL 12.5 g/50mLJul 15, 2026Sep 2, 2026
HF Acquisition Co LLC, DBA HealthFirstMANNITOL 12.5 g/50mLJul 15, 2026Sep 2, 2026
Hospira, Inc.MANNITOL 12.5 g/50mLJul 15, 2026Sep 2, 2026
ICU Medical Inc.MANNITOL 20 g/100mLJul 15, 2026Sep 2, 2026
ProPharma DistributionMANNITOL 250 mg/mLJul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Osmitrol — NDC 00338-0357-03," retrieved September 3, 2026, https://drugdashboards.com/drug/00338035703.

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