DrugDashboards

Sterile Water

Water · WATER 1000 mL/1000mL · Injection, Solution · Intravenous · Fresenius Kabi USA, LLC

NDC 63323-0178-76 · 10 BAG in 1 CASE / 1000 mL in 1 BAG · ANDA · View full market →

The short version

14 companies supply this market — deep enough that no single failure threatens the supply. It is in shortage right now.

The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.

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
$52.50
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)

$290,356
574 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)

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

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
ANDA209689
TE code
AP
Approval date
Nov 24, 2017
Patents / exclusivity
None on file

Shortage history

  • In shortage now — Sterile Water, Injection, 1 mL/1 mL (NDC 0641-6147-10)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, 1000 mL/1000 mL (NDC 63323-178-76)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, Solution)

LabelerStrengthFirst seenLast seen
American Regent, Inc.WATER 1 mL/mLJul 15, 2026Sep 3, 2026
Baxter Healthcare CompanyWATER 100 mL/100mLJul 15, 2026Sep 3, 2026
Siegfried Hameln GmbHWATER 1 mL/mLJul 15, 2026Sep 3, 2026
Becton Dickinson and CompanyWATER 1000 mL/1000mLJul 15, 2026Sep 2, 2026
Biocon Biologics Inc.WATER 1 mL/mLJul 15, 2026Sep 2, 2026
Civica, Inc.WATER 1 mL/mLJul 15, 2026Sep 2, 2026
Dr.Reddy's Laboratories Inc.,WATER 1 mL/mLJul 15, 2026Sep 2, 2026
Fresenius Kabi USA, LLCWATER 1000 mL/1000mLJul 15, 2026Sep 2, 2026
Fujian Genohope Biotech Ltd.WATER 1 mL/mLJul 15, 2026Sep 2, 2026
Henry Schein, Inc.WATER 1 mL/mLJul 15, 2026Sep 2, 2026
Hikma Pharmaceuticals USA Inc.WATER 1 mL/mLJul 15, 2026Sep 2, 2026
ICU Medical Inc.WATER 1 mL/mLJul 15, 2026Sep 2, 2026
ICU Medical Inc.WATER 1000 mL/1000mLJul 15, 2026Sep 2, 2026
Medical Purchasing Solutions, LLCWATER 1 mL/mLJul 15, 2026Sep 2, 2026
United Therapeutics CorporationWATER 1 mL/mLJul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Sterile Water — NDC 63323-0178-76," retrieved September 3, 2026, https://drugdashboards.com/drug/63323017876.

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