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Remifentanil Hydrochloride

Remifentanil Hydrochloride · REMIFENTANIL HYDROCHLORIDE 5 mg/5mL · Injection, Powder, Lyophilized, For Solution · Intravenous · Hikma Pharmaceuticals USA Inc.

NDC 00143-9393-10 · 10 VIAL in 1 CARTON / 10 mL in 1 VIAL · ANDA · View full market →

The short version

Just 3 companies supply this market — thin enough that a single exit would be felt immediately. 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
$2,600.00
Reported to Texas DSHS · 2026 annual filing · Hikma Pharmaceuticals USA Inc.

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

Supply fragility

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

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
ANDA210594
TE code
AP
Approval date
Oct 13, 2020
Patents / exclusivity
None on file

Shortage history

  • In shortage now Remifentanil Hydrochloride, Injection, 1 mg per vial (NDC 0143-9391-10)Jun 28, 2022
    Demand increase for the drug
    month 51 — 3× the typical 20-month injectable shortage · model puts 28% odds it resolves within 6 months
  • In shortage now Remifentanil Hydrochloride, Injection, 1 mg/1 mL (NDC 63323-723-03)Jun 28, 2022
    month 51 — 3× the typical 20-month injectable shortage · model puts 28% odds it resolves within 6 months
  • In shortage now Remifentanil Hydrochloride, Injection, 1 mg/1 mL (NDC 63323-724-05)Jun 28, 2022
    Delay in shipping of the drug
    month 51 — 3× the typical 20-month injectable shortage · model puts 28% odds it resolves within 6 months
  • In shortage now Remifentanil Hydrochloride, Injection, 1 mg/1 mL (NDC 63323-725-10)Jun 28, 2022
    month 51 — 3× the typical 20-month injectable shortage · model puts 28% odds it resolves within 6 months
  • In shortage now Remifentanil Hydrochloride, Injection, 2 mg per vial (NDC 0143-9392-10)Jun 28, 2022
    Demand increase for the drug
    month 51 — 3× the typical 20-month injectable shortage · model puts 28% odds it resolves within 6 months
  • In shortage now Remifentanil Hydrochloride, Injection, 5 mg per vial (NDC 0143-9393-10)Jun 28, 2022
    month 51 — 3× the typical 20-month injectable shortage · model puts 28% odds it resolves within 6 months
  • In shortage now Ultiva, Injection, 1 mg/1 mL (NDC 72078-034-01)Jun 28, 2022
    month 51 — 3× the typical 20-month injectable shortage · model puts 28% odds it resolves within 6 months
  • In shortage now Ultiva, Injection, 2 mg (NDC 72078-035-02)Jun 28, 2022
    month 51 — 3× the typical 20-month injectable shortage · model puts 28% odds it resolves within 6 months
  • In shortage now Ultiva, Injection, 5 mg (NDC 72078-036-05)Jun 28, 2022
    month 51 — 3× the typical 20-month injectable shortage · model puts 28% odds it resolves within 6 months

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of Remifentanil Hydrochloride (Injection, Powder, Lyophilized, For Solution)

LabelerStrengthFirst seenLast seen
Fresenius Kabi USA, LLCREMIFENTANIL HYDROCHLORIDE 1 mg/mLJul 15, 2026Sep 3, 2026
Mylan Institutional LLCREMIFENTANIL HYDROCHLORIDE 1 mg/mLJul 15, 2026Sep 3, 2026
Hikma Pharmaceuticals USA Inc.REMIFENTANIL HYDROCHLORIDE 1 mg/mLJul 15, 2026Sep 2, 2026
Hikma Pharmaceuticals USA Inc.REMIFENTANIL HYDROCHLORIDE 2 mg/2mLJul 15, 2026Sep 2, 2026
Hikma Pharmaceuticals USA Inc.REMIFENTANIL HYDROCHLORIDE 5 mg/5mLJul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Remifentanil Hydrochloride — NDC 00143-9393-10," retrieved September 3, 2026, https://drugdashboards.com/drug/00143939310.

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