DrugDashboards

Amikacin Sulfate

Amikacin Sulfate · AMIKACIN SULFATE 250 mg/mL · Injection, Solution · Intramuscular; Intravenous · Fresenius Kabi USA, LLC

NDC 63323-0815-04 · 10 VIAL, SINGLE-DOSE in 1 CARTON / 4 mL in 1 VIAL, SINGLE-DOSE · ANDA · View full market →

The short version

4 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 0.3% of the time — roughly 2× 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%)$0.6140per billing unit (100 MG)HCPCS J0278 · Jul 1, 2026
  • Part D plans paid (avg)$1.36per dosage unitgross, before rebates — matched by drug name · 2024
  • Federal contracts pay (FSS)$96.19per package of 10X4MLFresenius Kabi, LLC · May 15, 2025

Medicare Part D

All Part D pricing →

Matched to CMS's representative package for this drug (NDC 23155-0290-41) — 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
$3.22per unit
middle half $2.27$4.11 · 5,496 plans · Apr 1, 2026
Est. net of rebates
≈ $3.22
generic — rebates are minimal, so net ≈ gross
Coverage & restrictions
100%of plans cover it
tier 4 · prior auth 8% · 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.

Estimated fill cost

WAC per package, as filed
$233.00
Reported to Texas DSHS · 2026 annual filing · Fresenius Kabi USA

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

Medicare Part B (ASP)

Payment limit per 100 MG
$0.614
HCPCS J0278 · Jul 1, 2026 quarter · typically ASP + 6%

Medicaid spend (2025)

$1,299
45 prescriptions paid by Medicaid nationally · all Medicaid spend →

Supply fragility

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

90-day shortage risk (model v2)

0.3%chance of a new FDA shortage posting for amikacin sulfate (injectable) in the next 90 days

sterile injectable · sole-source market

For scale: the typical drug’s chance is about 0.1% — this one is 2× 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 $83.73 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
ANDA205604
TE code
AP
Approval date
Dec 9, 2015
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 Amikacin Sulfate (Injection, Solution)

LabelerStrengthFirst seenLast seen
Fresenius Kabi USA, LLCAMIKACIN SULFATE 250 mg/mLJul 15, 2026Sep 2, 2026
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.AMIKACIN SULFATE 1 g/4mLJul 15, 2026Sep 2, 2026
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.AMIKACIN SULFATE 250 mg/mLJul 15, 2026Sep 2, 2026
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.AMIKACIN SULFATE 500 mg/2mLJul 15, 2026Sep 2, 2026
Qilu Pharmaceutical Co., Ltd.AMIKACIN SULFATE 250 mg/mLJul 15, 2026Sep 2, 2026
Sagent PharmaceuticalsAMIKACIN SULFATE 250 mg/mLJul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Amikacin Sulfate — NDC 63323-0815-04," retrieved September 3, 2026, https://drugdashboards.com/drug/63323081504.

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