DrugDashboards

Sterile Water

Water · WATER 100 mL/100mL · Injection, Solution · Intravenous · Baxter Healthcare Company

NDC 00338-0013-06 · 2000 mL in 1 BAG · NDA · 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. One of its named manufacturing plants, Baxter Healthcare Corporation, failed FDA inspectionwithin the last two years — the agency’s most serious outcome.

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

$0$0.001$0.002$0.003Nov 2014Nov 2014$0.0021
1 price point · per · last surveyed Invalid DateSource: CMS NADAC

Estimated fill cost

WAC per package, as filed
$6.80
Reported to Texas DSHS · 2026 annual filing · Baxter Healthcare Corporation

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

Medicaid spend (2025)

$4.7M
19,988 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
NDA018632
TE code
AP
Approval date
Jun 30, 1982
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)

  • Class II · TerminatedApr 13, 2022
    Mckesson Medical-Surgical Inc. Corporate Office — cGMP deviations: Temperature abuse

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 00338-0013-06," retrieved September 3, 2026, https://drugdashboards.com/drug/00338001306.

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