The short version
Only one company currently supplies this market — there is no backup if it stumbles. 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.
Sterile Water
Sterile Water for Injection · WATER 100 mL/100mL · Injection, Solution · Intramuscular; Intravenous; Subcutaneous · Medefil, Inc.
NDC 64253-0020-30 · 60 SYRINGE, PLASTIC in 1 BOX / 10 mL in 1 SYRINGE, PLASTIC · ANDA · View full market →
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.
Medicaid spend (2023)
$92,099
35 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
- Medefil, Inc.United Statesmanufacture
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
- ANDA211188
- TE code
- AP
- Approval date
- Dec 2, 2019
- Patents / exclusivity
- None on file
Shortage history
- In shortage now — Sterile Water, Injection, 10 mL/10 mL (NDC 64253-020-30)Nov 23, 2021month 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 Sterile Water for Injection (Injection, Solution)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Medefil, Inc. | WATER 100 mL/100mL | 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 64253-0020-30," retrieved September 3, 2026, https://drugdashboards.com/drug/64253002030.
Free to cite with attribution — see how the data is put together.