DrugDashboards

Gentamicin Sulfate

Gentamicin Sulfate · GENTAMICIN SULFATE 40 mg/mL · Injection, Solution · Intramuscular; Intravenous · Henry Schein, Inc.

NDC 00404-9865-02 · 1 VIAL, SINGLE-DOSE in 1 BAG / 2 mL in 1 VIAL, SINGLE-DOSE · ANDA · View full market →

The short version

8 companies supply this market — a reasonable cushion if one runs into trouble. 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)$1.41per dosage unitgross, before rebates — matched by drug name · 2024

Medicare Part D

All Part D pricing →

Matched to CMS's representative package for this drug (NDC 00409-1207-03) — same generic, strength, and dosage form. CMS prices one NDC per drug concept, not every package.

ⓘ How this was built
Data sources
  • CMS quarterly Prescription Drug Plan Formulary & Pricing files (SPUF)
Method

Negotiated 30-day point-of-sale unit prices and formulary terms aggregated across every unsuppressed Part D and MA-PD plan for the quarter shown. Point of sale means gross of confidential rebates. CMS publishes one representative NDC per drug concept (RxCUI) rather than every package, so these figures come from CMS's representative package for the same drug — matched on generic name, strength, and dosage form. Estimated from MedPAC's program-wide rebate aggregates (June 2023: DIR = 29% of gross Part D spending; brand rebates ≈ 25–40% of gross, generics minimal). Actual rebates are confidential and vary widely by drug — this is a range, not a fact about this drug.

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

Plans pay at point of sale
$1.52per unit
middle half $0.9703$1.91 · 5,495 plans · Apr 1, 2026
Est. net of rebates
≈ $1.52
generic — rebates are minimal, so net ≈ gross
Coverage & restrictions
100%of plans cover it
tier 4 · prior auth 7% · step therapy 0% · qty limit 0%

*No drug-level rebate is public — the estimate applies MedPAC's program-wide brand rebate range to this drug's gross price. Tracked here for 10 quarters since 2024.

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 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 →

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 $47.16 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
ANDA062420
TE code
AP
Approval date
Aug 15, 1983
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 — NDC 00404-9865-02," retrieved September 3, 2026, https://drugdashboards.com/drug/00404986502.

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