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Gentamicin Sulfate in Sodium Chloride

Gentamicin Sulfate · GENTAMICIN SULFATE 100 mg/50mL · Injection, Solution · Intravenous · Baxter Healthcare Corporation

NDC 00338-0511-41 · 50 mL in 1 BAG · ANDA · 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. Historically, drugs in this position went on to a new shortage within 90 days about 0.4% of the time — roughly 3× the typical drug (0.1%).

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%)$1.93per billing unit (80 MG)HCPCS J1580 · Jul 1, 2026
  • Part D plans paid (avg)$8.80per dosage unitgross, before rebates — matched by drug name · 2024
  • Federal contracts pay (FSS)$58.80per package of 24X50MLBaxter 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
$4.15
Reported to Texas DSHS · 2026 annual filing · Baxter Healthcare Corporation

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

Medicare Part B (ASP)

Payment limit per 80 MG
$1.925
HCPCS J1580 · Jul 1, 2026 quarter · typically ASP + 6%

Supply fragility

Not scored — fragility is computed for NADAC-priced NDCs.

90-day shortage risk (model v2)

0.4%chance of a new FDA shortage posting for gentamicin sulfate (injectable) in the next 90 days

sterile injectable · OAI inspection at a producing facility (24 months) · sole-source market

For scale: the typical drug’s chance is about 0.1% — this one is 3× that.

Backtested statistical model over the whole market, not this package alone. Model details →

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 · avg $31.16 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
ANDA062373
TE code
Approval date
Sep 7, 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 Gentamicin Sulfate (Injection, Solution)

LabelerStrengthFirst seenLast seen
Medical Purchasing Solutions, LLCGENTAMICIN SULFATE 40 mg/mLJul 15, 2026Sep 3, 2026
Baxter Healthcare CorporationGENTAMICIN SULFATE 100 mg/50mLJul 15, 2026Sep 2, 2026
Baxter Healthcare CorporationGENTAMICIN SULFATE 100 mg/100mLJul 15, 2026Sep 2, 2026
Baxter Healthcare CorporationGENTAMICIN SULFATE 60 mg/50mLJul 15, 2026Sep 2, 2026
Baxter Healthcare CorporationGENTAMICIN SULFATE 80 mg/100mLJul 15, 2026Sep 2, 2026
Baxter Healthcare CorporationGENTAMICIN SULFATE 80 mg/50mLJul 15, 2026Sep 2, 2026
Cardinal Health 107, LLCGENTAMICIN SULFATE 40 mg/mLJul 15, 2026Sep 2, 2026
Henry Schein, IncGENTAMICIN SULFATE 40 mg/mLJul 15, 2026Sep 2, 2026
Henry Schein, Inc.GENTAMICIN SULFATE 40 mg/mLJul 15, 2026Sep 2, 2026
HF Acquisition Co LLC, DBA HealthFirstGENTAMICIN SULFATE 40 mg/mLJul 15, 2026Sep 2, 2026
Hospira, Inc.GENTAMICIN SULFATE 40 mg/mLJul 15, 2026Sep 2, 2026
Fresenius Kabi USA, LLCGENTAMICIN SULFATE 40 mg/mLJul 15, 2026Aug 28, 2026

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

Cite this page

DrugDashboards, "Gentamicin Sulfate in Sodium Chloride — NDC 00338-0511-41," retrieved September 3, 2026, https://drugdashboards.com/drug/00338051141.

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