DrugDashboards

Amikacin Sulfate

Amikacin Sulfate · AMIKACIN SULFATE 250 mg/mL · Injection · Intramuscular; Intravenous · Hikma Pharmaceuticals USA Inc.

NDC 00641-6167-10 · 10 VIAL, SINGLE-DOSE in 1 CARTON / 2 mL in 1 VIAL, SINGLE-DOSE · ANDA · View full market →

The short version

Just 2 companies supply this market — thin enough that a single exit would be felt immediately. The price is down 28% over the past year, to $2.30 per mL. Put together: worth watching — several of the pressures that precede supply trouble are present at once. 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.

  • Pharmacies pay (NADAC)$2.30per MLinvoice-surveyed acquisition cost · Aug 19, 2026
  • 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

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

$0$2.00$4.00Apr 2025Sep 2026$2.30
12 price points · per MLSource: CMS NADAC

Estimated fill cost

WAC per package, as filed
$80.00
Reported to Texas DSHS · 2026 annual filing · Hikma Pharmaceuticals USA Inc.

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%

Supply fragility

38● Elevated risk

The score is counting real pressure here. One of these alone is routine; it’s the combination that makes this market worth watching.

  • 2 active manufacturers+20
  • price down 24% year over year+8
  • sterile injectable+10

The score counts pressure that is already visible — fewer makers, shortages, recalls, falling prices. 0 means none of it; 100 means all of it at once. Recomputed daily · as of Sep 3, 2026

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
ANDA063315
TE code
AP
Approval date
Apr 11, 1994
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)

LabelerStrengthFirst seenLast seen
Mullan Pharmaceutical Inc.AMIKACIN SULFATE 250 mg/mLJul 15, 2026Aug 31, 2026
Hikma Pharmaceuticals USA Inc.AMIKACIN SULFATE 250 mg/mLJul 15, 2026Aug 28, 2026

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

Cite this page

DrugDashboards, "Amikacin Sulfate — NDC 00641-6167-10," retrieved September 3, 2026, https://drugdashboards.com/drug/00641616710.

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