Sterile Water

Water · WATER 100 mL/100mL · Irrigant · Irrigation · Baxter Healthcare Corporation

NDC 00338-0004-04 · 12 BOTTLE, PLASTIC in 1 CARTON / 1000 mL in 1 BOTTLE, PLASTIC · NDA · View full market →

The short version

Just 3 companies supply this market — thin enough that a single exit would be felt immediately. The price has fallen 40% in a year, to $0.0009 per unit — and generics that get this cheap tend to get abandoned rather than defended. It is in shortage right now — FDA lists the reason as “demand increase for the drug”. A Class II recall hit this product in the past year (Baxter Healthcare Corporation). 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

10 price points · per · last surveyed Invalid DateSource: CMS NADAC

Estimated fill cost

WAC per package, as filed

$4.05

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)

$1.1M

40,580 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 water (other) in the next 90 days

price up 35% YoY · OAI inspection at a producing facility (24 months) · 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

Baxter Healthcare CorporationOAIUnited States
analysis · label · manufacture · pack · sterilize
Baxter Healthcare CorporationOAIUnited States
analysis

Establishments this product's FDA label declares, located via FDA registration data. How we built this →

Regulatory

Application: NDA017428
TE code: AT
Approval date: Jan 1, 1982
Patents / exclusivity: None on file

Shortage history

In shortage now — Sterile Water In Plastic Container, Irrigant, 1 mL/1 mL (NDC 0264-2101-00)Apr 28, 2023
month 41 — 3× the typical 12-month other shortage
In shortage now — Sterile Water In Plastic Container, Irrigant, 1 mL/1 mL (NDC 0264-2101-10)Apr 28, 2023
month 41 — 3× the typical 12-month other shortage
In shortage now — Sterile Water, Irrigant, 100 mL/100 mL (NDC 0338-0004-02)Apr 28, 2023
month 41 — 3× the typical 12-month other shortage
In shortage now — Sterile Water, Irrigant, 100 mL/100 mL (NDC 0338-0004-03)Apr 28, 2023
Demand increase for the drug
month 41 — 3× the typical 12-month other shortage
In shortage now — Sterile Water, Irrigant, 100 mL/100 mL (NDC 0338-0004-04)Apr 28, 2023
Demand increase for the drug
month 41 — 3× the typical 12-month other shortage

Recalls (this NDC)

Class II · OngoingDec 22, 2025
Baxter Healthcare Corporation — Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution

Manufacturers of Water (Irrigant)

Labeler	Strength	First seen	Last seen
Baxter Healthcare Corporation	WATER 100 mL/100mL	Jul 15, 2026	Sep 3, 2026
B. Braun Medical Inc.	WATER 1 mL/mL	Jul 15, 2026	Sep 2, 2026
ICU Medical Inc.	WATER 1 mL/mL	Jul 15, 2026	Sep 2, 2026

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

Cite this page

DrugDashboards, "Sterile Water — NDC 00338-0004-04," retrieved September 3, 2026, https://drugdashboards.com/drug/00338000404.

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