DrugDashboards

Sterile Diluent for Remodulin

water · WATER 1 mL/mL · Injection, Solution · Intravenous · United Therapeutics Corporation

NDC 66302-0150-50 · 1 VIAL in 1 BOX / 50 mL in 1 VIAL · 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.

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
$12.63
Reported to Texas DSHS · 2026 annual filing · United Therapeutics Corporation

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

Medicaid spend (2025)

$913,722
199 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 →

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
NDA021272
TE code
AP
Approval date
May 21, 2002
Patents / exclusivity
40 patents, 0 exclusivities
TypeNumber / codeExpires
patent7999007Mar 29, 2029
patent7999007Mar 29, 2029
patent7999007Mar 29, 2029
patent7999007Mar 29, 2029
patent7999007Mar 29, 2029
patent7999007Mar 29, 2029
patent7999007Mar 29, 2029
patent7999007Mar 29, 2029
patent9593066Dec 15, 2028
patent11723887Dec 15, 2028
patent11723887Dec 15, 2028
patent11723887Dec 15, 2028

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 Diluent for Remodulin — NDC 66302-0150-50," retrieved September 3, 2026, https://drugdashboards.com/drug/66302015050.

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