Sterile Water

Water · WATER 1 mL/mL · Injection · Intramuscular; Intravenous; Subcutaneous · Fresenius Kabi USA, LLC

NDC 63323-0185-10 · 25 VIAL in 1 TRAY / 10 mL in 1 VIAL · ANDA · View full market →

The short version

12 companies supply this market — deep enough that no single failure threatens the supply. The generic price has jumped 212% in a year, to $0.3076 per mL — sharp rises like this often mean supply is already tightening. It is in shortage right now — FDA lists the reason as “demand increase for the drug”. Put together: worth watching — several of the pressures that precede supply trouble are present at once.

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)$0.3076per MLinvoice-surveyed acquisition cost · Aug 19, 2026
Federal contracts pay (FSS)$93.55per package of 25X10MLFresenius Kabi, LLC · May 15, 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

59 price points · per MLSource: CMS NADAC

Estimated fill cost

WAC per package, as filed

$125.00

Reported to Texas DSHS · 2026 annual filing · Fresenius Kabi USA

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

Medicaid spend (2025)

$917,263

5,868 prescriptions paid by Medicaid nationally · all Medicaid spend →

Supply fragility

43● 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.

in shortage now+25
Class I/II recall on same molecule/form in past 12 months+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)

1.6%chance of a new FDA shortage posting for water (injectable) in the next 90 days

price up 205% YoY · sterile injectable · OAI inspection at a producing facility (24 months)

For scale: the typical drug’s chance is about 0.1% — this one is 11× that.

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

Where it's made

Fresenius Kabi USA, LLCUnited States
analysis · manufacture
Fresenius Kabi USA, LLCUnited States
manufacture

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
Biologic (BLA)
Injectable / infused
Orphan-drug exclusivity
REMS program

Regulatory

Application: ANDA088400
TE code: AP
Approval date: Jan 16, 1984
Patents / exclusivity: None on file

Shortage history

In shortage now — Sterile Water For Injection In Plastic Container, Injection, 1 mL/1 mL (NDC 63323-185-10)Nov 23, 2021
Demand increase for the drug
month 58 — 3× the typical 20-month injectable shortage · model puts 26% odds it resolves within 6 months
In shortage now — Sterile Water For Injection In Plastic Container, Injection, 1 mL/1 mL (NDC 63323-185-20)Nov 23, 2021
month 58 — 3× the typical 20-month injectable shortage · model puts 26% odds it resolves within 6 months
In shortage now — Sterile Water For Injection In Plastic Container, Injection, 1 mL/1 mL (NDC 63323-185-50)Nov 23, 2021
month 58 — 3× the typical 20-month injectable shortage · model puts 26% odds it resolves within 6 months
In shortage now — Sterile Water, Injection, 1 mL/1 mL (NDC 0409-4887-10)Nov 23, 2021
month 58 — 3× the typical 20-month injectable shortage · model puts 26% odds it resolves within 6 months
In shortage now — Sterile Water, Injection, 1 mL/1 mL (NDC 0409-4887-20)Nov 23, 2021
month 58 — 3× the typical 20-month injectable shortage · model puts 26% odds it resolves within 6 months
In shortage now — Sterile Water, Injection, 1 mL/1 mL (NDC 0409-4887-50)Nov 23, 2021
month 58 — 3× the typical 20-month injectable shortage · model puts 26% odds it resolves within 6 months
In shortage now — Sterile Water, Injection, 1 mL/1 mL (NDC 0409-4887-99)Nov 23, 2021
month 58 — 3× the typical 20-month injectable shortage · model puts 26% odds it resolves within 6 months

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of Water (Injection)

Labeler	Strength	First seen	Last seen
Fresenius Kabi USA, LLC	WATER 1 mL/mL	Jul 15, 2026	Sep 3, 2026
Hospira, Inc.	WATER 1 mL/mL	Jul 15, 2026	Sep 3, 2026
Patheon Manufacturing Services LLC	WATER 1 mL/mL	Jul 15, 2026	Sep 3, 2026
ProPharma Distribution	WATER 1 mL/mL	Jul 15, 2026	Sep 3, 2026
A-S Medication Solutions	WATER 1 mL/mL	Jul 15, 2026	Sep 2, 2026
Asclemed USA, Inc.	WATER 1 mL/mL	Jul 15, 2026	Sep 2, 2026
B. Braun Medical Inc.	WATER 1 mL/mL	Jul 15, 2026	Sep 2, 2026
Becton Dickinson and Company	WATER 1 mL/mL	Jul 15, 2026	Sep 2, 2026
Medical Purchasing Solutions, LLC	WATER 1 mL/mL	Jul 15, 2026	Sep 2, 2026
Remedyrepack Inc.	WATER 1 mL/mL	Aug 26, 2026	Sep 2, 2026
Henry Schein, Inc.	WATER 1 mL/mL	Jul 15, 2026	Aug 31, 2026
Cardinal Health 107, LLC	WATER 1 mL/mL	Jul 15, 2026	Aug 29, 2026

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

Cite this page

DrugDashboards, "Sterile Water — NDC 63323-0185-10," retrieved September 3, 2026, https://drugdashboards.com/drug/63323018510.

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