Precedex

Dexmedetomidine Hydrochloride · DEXMEDETOMIDINE HYDROCHLORIDE 4 ug/mL · Injection, Solution · Intravenous · Hospira, Inc.

NDC 00409-1596-10 · 10 CARTON in 1 CASE / 1 BOTTLE in 1 CARTON / 100 mL in 1 BOTTLE · NDA · View full market →

The short version

12 companies supply this market — deep enough that no single failure threatens the supply. It is in shortage right now — FDA lists the reason as “demand increase for the drug”.

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

$500.00

Reported to Texas DSHS · 2026 annual filing · Pfizer Inc.

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

Medicaid spend (2025)

$107

11 prescriptions paid by Medicaid nationally · all Medicaid spend →

Supply fragility

Not scored — fragility is computed for NADAC-priced NDCs.

Where it's made

Hospira, Inc.United States
analysis · label · manufacture · pack
Hospira, Inc.United States
analysis · label · manufacture · pack

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: NDA021038
TE code: AP
Approval date: Dec 17, 1999
Patents / exclusivity: 38 patents, 0 exclusivities

Type	Number / code	Expires
patent	8455527*PED	Jul 4, 2032
patent	8242158*PED	Jul 4, 2032
patent	8338470*PED	Jul 4, 2032
patent	8455527*PED	Jul 4, 2032
patent	8242158*PED	Jul 4, 2032
patent	8338470*PED	Jul 4, 2032
patent	8648106*PED	Jul 4, 2032
patent	8648106*PED	Jul 4, 2032
patent	8648106*PED	Jul 4, 2032
patent	8242158*PED	Jul 4, 2032
patent	8455527*PED	Jul 4, 2032
patent	8338470*PED	Jul 4, 2032

Shortage history

In shortage now — Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 63323-421-02)Apr 10, 2020
Demand increase for the drug
month 77 — 4× the typical 20-month injectable shortage · model puts 24% odds it resolves within 6 months
In shortage now — Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 70069-758-04)Apr 10, 2020
month 77 — 4× the typical 20-month injectable shortage · model puts 24% odds it resolves within 6 months
In shortage now — Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 70069-759-04)Apr 10, 2020
month 77 — 4× the typical 20-month injectable shortage · model puts 24% odds it resolves within 6 months
In shortage now — Dexmedetomidine Hydrochloride, Injection, 200 ug/50 mL (NDC 67457-924-50)Apr 10, 2020
month 77 — 4× the typical 20-month injectable shortage · model puts 24% odds it resolves within 6 months
In shortage now — Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 42023-186-20)Apr 10, 2020
Other
month 77 — 4× the typical 20-month injectable shortage · model puts 24% odds it resolves within 6 months
In shortage now — Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 42023-187-10)Apr 10, 2020
Other
month 77 — 4× the typical 20-month injectable shortage · model puts 24% odds it resolves within 6 months
In shortage now — Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 43598-975-58)Apr 10, 2020
month 77 — 4× the typical 20-month injectable shortage · model puts 24% odds it resolves within 6 months
In shortage now — Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 43598-976-58)Apr 10, 2020
month 77 — 4× the typical 20-month injectable shortage · model puts 24% odds it resolves within 6 months
In shortage now — Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 70121-1388-8)Apr 10, 2020
month 77 — 4× the typical 20-month injectable shortage · model puts 24% odds it resolves within 6 months
In shortage now — Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 70121-1389-7)Apr 10, 2020
month 77 — 4× the typical 20-month injectable shortage · model puts 24% odds it resolves within 6 months
In shortage now — Dexmedetomidine Hydrochloride, Injection, 400 ug/100 mL (NDC 67457-925-10)Apr 10, 2020
month 77 — 4× the typical 20-month injectable shortage · model puts 24% odds it resolves within 6 months
In shortage now — Precedex, Injection, 1000 mcg/250 mL (NDC 0409-7875-12)Apr 10, 2020
month 77 — 4× the typical 20-month injectable shortage · model puts 24% odds it resolves within 6 months
In shortage now — Precedex, Injection, 1000 mcg/250 mL Glass Bottle NovaPlus (NDC 0409-2815-01)Apr 10, 2020
month 77 — 4× the typical 20-month injectable shortage · model puts 24% odds it resolves within 6 months
In shortage now — Precedex, Injection, 1000 mcg/250 mL Single Dose Glass Bottle (NDC 0409-1434-01)Apr 10, 2020
month 77 — 4× the typical 20-month injectable shortage · model puts 24% odds it resolves within 6 months
In shortage now — Precedex, Injection, 200 mcg/50 mL (4 mcg/mL) (NDC 0409-1454-20)Apr 10, 2020
month 77 — 4× the typical 20-month injectable shortage · model puts 24% odds it resolves within 6 months
In shortage now — Precedex, Injection, 200 mcg/50 mL (4 mcg/mL) (NDC 0409-1660-50)Apr 10, 2020
month 77 — 4× the typical 20-month injectable shortage · model puts 24% odds it resolves within 6 months
In shortage now — Precedex, Injection, 200 mcg/50 mL (4 mcg/mL) (NDC 0409-4596-20)Apr 10, 2020
month 77 — 4× the typical 20-month injectable shortage · model puts 24% odds it resolves within 6 months
In shortage now — Precedex, Injection, 200 mcg/50 mL (NDC 0409-7838-24)Apr 10, 2020
month 77 — 4× the typical 20-month injectable shortage · model puts 24% odds it resolves within 6 months
In shortage now — Precedex, Injection, 400 mcg/100 mL (4 mcg/mL) (NDC 0409-0155-02)Apr 10, 2020
month 77 — 4× the typical 20-month injectable shortage · model puts 24% odds it resolves within 6 months
In shortage now — Precedex, Injection, 400 mcg/100 mL (4 mcg/mL) (NDC 0409-1174-10)Apr 10, 2020
month 77 — 4× the typical 20-month injectable shortage · model puts 24% odds it resolves within 6 months

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of Dexmedetomidine Hydrochloride (Injection, Solution)

Labeler	Strength	First seen	Last seen
Amneal Pharmaceuticals LLC	DEXMEDETOMIDINE HYDROCHLORIDE 4 ug/mL	Jul 15, 2026	Sep 3, 2026
Fresenius Kabi USA, LLC	DEXMEDETOMIDINE HYDROCHLORIDE 100 ug/mL	Jul 15, 2026	Sep 3, 2026
Hikma Pharmaceuticals USA Inc.	DEXMEDETOMIDINE HYDROCHLORIDE 4 ug/mL	Jul 15, 2026	Sep 3, 2026
Hospira, Inc.	DEXMEDETOMIDINE HYDROCHLORIDE 4 ug/mL	Jul 15, 2026	Sep 3, 2026
Medical Purchasing Solutions, LLC	DEXMEDETOMIDINE HYDROCHLORIDE 100 ug/mL	Jul 15, 2026	Sep 3, 2026
Somerset Therapeutics, LLC	DEXMEDETOMIDINE HYDROCHLORIDE 100 ug/mL	Jul 15, 2026	Sep 3, 2026
Mylan Institutional LLC	DEXMEDETOMIDINE HYDROCHLORIDE 200 ug/50mL	Jul 15, 2026	Sep 2, 2026
Mylan Institutional LLC	DEXMEDETOMIDINE HYDROCHLORIDE 400 ug/100mL	Jul 15, 2026	Sep 2, 2026
Sagent Pharmaceuticals	DEXMEDETOMIDINE HYDROCHLORIDE 4 ug/mL	Jul 15, 2026	Sep 2, 2026
Sun Pharmaceuticals Industries, Inc.	DEXMEDETOMIDINE HYDROCHLORIDE 100 ug/mL	Jul 15, 2026	Sep 2, 2026
Dr.Reddy's Laboratories Inc	DEXMEDETOMIDINE HYDROCHLORIDE 4 ug/mL	Jul 15, 2026	Aug 31, 2026
Par Health USA, LLC	DEXMEDETOMIDINE HYDROCHLORIDE 4 ug/mL	Jul 15, 2026	Aug 28, 2026
Precision Dose, Inc.	DEXMEDETOMIDINE HYDROCHLORIDE 4 ug/mL	Jul 15, 2026	Aug 28, 2026

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

Cite this page

DrugDashboards, "Precedex — NDC 00409-1596-10," retrieved September 3, 2026, https://drugdashboards.com/drug/00409159610.

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