Home › NDC Lookup › Drug shortages › Remifentanil Hydrochloride Injection

Remifentanil Hydrochloride Injection shortage

Remifentanil Hydrochloride Injection is currently listed in shortage by the FDA. The FDA lists 9 affected products. The reported reason: Demand increase for the drug; Delay in shipping of the drug. This page was last refreshed from FDA data on Oct 4, 2026.

Current ⚠ Supply risk: Low Controlled substance Analgesia/Addiction 9 products 3 manufacturers 1,559 days · 4.3 yr First posted Jun 28, 2022 Updated Sep 18, 2026
Here’s the bottom line

The 1 mg/vial and 2 mg/vial sizes of remifentanil hydrochloride injection are currently hard to find, while the 1 mg/mL, 2 mg, and 5 mg sizes still have available supply. Ultiva (remifentanil hydrochloride) 1 mg/mL is listed as available from manufacturers not reporting a shortage.

Don’t stop or change your therapy on your own — ask your pharmacist about other manufacturers (see options) and your prescriber about a long-term plan.

Do you take this drug? See the ‘What to do’ recommendation from Dr. Brian Staiger, PharmD →
9
Affected NDCs
3
Reporting manufacturers
3/3
Reporting mfrs supplying
4/6
Affected strengths supplied
33%
NDCs unavailable
1,559
Days in shortage
906
Medicaid Rx (2025)
Source: FDA Drug Shortages Database API (openFDA). Last refreshed Oct 4, 2026 · today

What’s in shortage — at a glance

These figures count only the manufacturers that reported this shortage to the FDA — not every company that makes Remifentanil Hydrochloride Injection. Other makers that haven’t reported a problem are shown in the green card below.

Availability of affected NDCs
From the FDA shortage report
9 NDCs
Available 6 Unavailable 3
Affected strengths still supplied
Among manufacturers reporting this shortage
4/6 strengths
Sourceable 4 No supply 2
FDA-reporting manufacturers with supply
Among manufacturers reporting this shortage
3/3 makers
With supply 3
✓ Other manufacturers not reporting a shortage
Still-marketed Remifentanil Hydrochloride Injection from companies that have not filed an FDA shortage — these are not counted in the figures above. Stock can still vary by pharmacy.
Fresenius Kabi USA, LLC Mylan Institutional LLC
See all other options & details →
Shortage timeline
  1. Sep 18, 2026
    Currently in shortage
    9 of 9 products affected.
  2. Sep 17, 2026
    FDA refreshed this shortage record
    3 products updated.
  3. Sep 15, 2026
    FDA refreshed this shortage record
    3 products updated.
  4. Jun 28, 2022
    First reported to the FDA
    9 products first listed.

Built from FDA posting and update dates. The end date FDA publishes is the posting/update date, not a true resolution date, so durations are approximate.

What exactly is on backorder — by manufacturer

Manufacturer: Fresenius Kabi USA, LLC 📞 888-386-1300 3 NDCS click to expand
Status NDC / product Strength Availability Related information Reason
Current Remifentanil Hydrochloride, Injection, 1 mg/1 mL (NDC 63323-725-10) NDC 63323-0725-10 — Available Check wholesalers for inventory —
Current Remifentanil Hydrochloride, Injection, 1 mg/1 mL (NDC 63323-723-03) NDC 63323-0723-03 — Available Check wholesalers for inventory —
Current Remifentanil Hydrochloride, Injection, 1 mg/1 mL (NDC 63323-724-05) NDC 63323-0724-05 — Unavailable Next release September 2026. Check wholesalers for inventory. Delay in shipping of the drug
Manufacturer: Hikma Pharmaceuticals USA, Inc. 📞 800-631-2174 3 NDCS click to expand
Status NDC / product Strength Availability Related information Reason
Current Remifentanil Hydrochloride, Injection, 5 mg per vial (NDC 0143-9393-10) NDC 00143-9393-10 — Available Additional lots will be available. Product will be made available as it is released. —
Current Remifentanil Hydrochloride, Injection, 2 mg per vial (NDC 0143-9392-10) NDC 00143-9392-10 — Unavailable Estimated recovery: TBD Demand increase for the drug
Current Remifentanil Hydrochloride, Injection, 1 mg per vial (NDC 0143-9391-10) NDC 00143-9391-10 — Unavailable Estimated recovery: TBD Demand increase for the drug
Manufacturer: Mylan Institutional, a Viatris Company 📞 800-796-9526 3 NDCS click to expand
Status NDC / product Strength Availability Related information Reason
Current Ultiva, Injection, 1 mg/1 mL (NDC 72078-034-01) NDC 72078-0034-01 — Available — —
Current Ultiva, Injection, 5 mg (NDC 72078-036-05) NDC 72078-0036-05 — Available — —
Current Ultiva, Injection, 2 mg (NDC 72078-035-02) NDC 72078-0035-02 — Available — —

These rows are manufacturer reports to the FDA for Remifentanil Hydrochloride Injection — they do not necessarily cover every manufacturer that makes this drug. A company appears here only if it told the FDA it has a supply problem, so other makers may still have stock. That’s the basis for the Where else can I get Remifentanil Hydrochloride Injection? options further down this page.

Why is Remifentanil Hydrochloride Injection in shortage?

There are two different reasons behind this shortage, depending on the manufacturer. For Fresenius Kabi, one specific package of their 1 mg/1 mL remifentanil (NDC 63323-724-05) is currently unavailable due to a shipping delay — meaning the product exists but hasn't been able to get out to wholesalers yet. Their next release for that particular package is expected in September 2026. Importantly, Fresenius Kabi does have two other 1 mg/1 mL packages of this medication that are still available right now.

For Hikma Pharmaceuticals, their 1 mg and 2 mg vials are both currently unavailable because more people need this medication than they can keep up with — a demand increase. There's no firm recovery date yet for those two sizes (listed as "to be determined"). However, Hikma's 5 mg vials are still available, and the company says additional lots will be released as they're ready. This report reflects only what these specific manufacturers have shared with the FDA — it doesn't speak to every maker of this drug.

FDA reason code(s): Demand increase for the drug; Delay in shipping of the drug

Based on the manufacturer-reported reason(s) and notes on file with the FDA for Remifentanil Hydrochloride Injection, summarized in plain English by HelloPharmacist. A drug can be short for more than one reason, and the FDA updates these as manufacturers report changes.

What should I do if I take Remifentanil Hydrochloride Injection?

Remifentanil Hydrochloride Injection is currently on the FDA shortage list. This is a hospital medicine given by injection, so your care team controls which supply they use.

The strengths that still have an available source are the 1 mg/1 mL, 2 mg, 5 mg, and 5 mg per vial products. The two strengths with no available source right now are the 1 mg per vial and the 2 mg per vial. So most forms of this medicine are still being supplied.

The reported reasons are increased demand and a shipping delay. All three manufacturers on this record are still reporting some available supply, which is reassuring. For the unavailable strengths, recovery dates are listed as to-be-determined; one maker notes a next release around September 2026, and another expects additional lots as they are released.

What you can do:

  • Do not skip, stop, or change your dose on your own.
  • If your strength still has supply, ask your pharmacy to order it — they can check wholesalers and other manufacturers.
  • This same medicine is also available from another maker, so your pharmacy may be able to source one of those, though it may not be in local stock.
  • If your exact strength cannot be found, ask your prescriber or pharmacist about options.

Manufacturer contact numbers are listed on this page for reference; pharmacies usually handle those calls.

See “Where else can I get Remifentanil Hydrochloride Injection?” below ↓ The same medicine from manufacturers not reporting a shortage, alternative dosage forms, and therapeutic equivalents with pricing.
If you are a patient:
  • Don’t stop or change the medication on your own — talk to your prescriber first.
  • If this is part of an ongoing or essential regimen (for example HIV treatment or prevention, seizure, heart, transplant, diabetes or mental-health medicines), do not skip or ration doses — contact your pharmacist or prescriber right away to arrange continued supply before you run out.
  • Ask your pharmacy to check other manufacturers, strengths, package sizes, and nearby stores.
  • Ask your prescriber whether a different strength, formulation, or the brand/generic version is appropriate.
  • This is a controlled substance. Transfers between pharmacies and switching strengths have extra federal/state rules — ask the pharmacy before you assume a transfer is possible.
Keep reading
Our full Remifentanil guide

Uses, dosing, side effects, prices, and the complete FDA label — written in plain English and pharmacist-reviewed.

Read the Remifentanil guide →

Where else can I get Remifentanil Hydrochloride Injection?

FDA shortages are manufacturer-reported — a company only shows up on the shortage list if it told the FDA it has a supply problem, so not every maker of Remifentanil Hydrochloride Injection is necessarily short. Below we pull together the other still-marketed options that are not reported in shortage: the same medicine from manufacturers that haven’t reported a problem, and alternative dosage forms. These may still be out of stock at your pharmacy, and only your prescriber or pharmacist can decide what’s right for you.

Same medicine, other manufacturers (not reported short)

Same active ingredient, dosage form & route as the shortage (matched on the FDB HICL ingredient code), from makers that have not filed a shortage with the FDA:

ProductStrengthForm / routeManufacturerNDC
Remifentanil Hydrochloride REMIFENTANIL HYDROCHLORIDE 1 mg/mL Injection, Powder, Lyophilized, For Solution · Intravenous Fresenius Kabi USA, LLC 63323-0723-06
Ultiva REMIFENTANIL HYDROCHLORIDE 1 mg/mL Injection, Powder, Lyophilized, For Solution · Intravenous Mylan Institutional LLC 67457-0912-01
Therapeutic equivalents & pricing 12 productsclick to expand

Orange Book–rated equivalents of the affected strengths, with the latest NADAC price (a federal retail-acquisition benchmark, not your copay) and an evidence-based availability label. Cheapest first.

ProductManufacturerPackageNADAC $/unitAB ratingAvailability
Remifentanil Hydrochloride 5 mg/5mLNDC 00143-9393-10 Hikma 10 vials — AP FDA listed
Remifentanil Hydrochloride 1 mg/mLNDC 63323-0725-10 Fresenius 10 vials — AP FDA listed
Ultiva 1 mg/mLNDC 67457-0914-05 Mylan 10 vials — AP FDA listed
Ultiva 1 mg/mLNDC 72078-0036-05 Mylan 10 vials — AP FDA listed
Remifentanil Hydrochloride 1 mg/mLNDC 00143-9391-10 Hikma 10 vials — AP FDA listed
Ultiva 1 mg/mLNDC 67457-0913-02 Mylan 10 vials — AP FDA listed
Remifentanil Hydrochloride 1 mg/mLNDC 63323-0724-05 Fresenius 10 vials — AP FDA listed
Remifentanil Hydrochloride 1 mg/mLNDC 63323-0723-03 Fresenius 10 vials — AP FDA listed
Ultiva 1 mg/mLNDC 72078-0035-02 Mylan 10 vials — AP FDA listed
Ultiva 1 mg/mLNDC 67457-0912-01 Mylan 10 vials — AP FDA listed
Ultiva 1 mg/mLNDC 72078-0034-01 Mylan 10 vials — AP FDA listed
Remifentanil Hydrochloride 2 mg/2mLNDC 00143-9392-10 Hikma 10 vials — AP FDA listed

Equivalents share the same ingredient, strength, dosage form and route; an AB rating means the FDA considers them substitutable. NADAC is a national retail-pharmacy acquisition benchmark from CMS — not what you pay. Availability is inferred from recent pricing, not a stock check.

Other drugs in the same treatment class

These are different medicines — not other versions of Remifentanil Hydrochloride Injection — that fall in the same broad treatment class (opioid analgesic, anesthetic adjunct agents) . They are not automatic substitutes: they can differ in how they work, dosing, effectiveness, side effects and what they’re approved to treat. Do not switch on your own. This list is for information only — ask your prescriber or pharmacist whether any of them is appropriate for you.

Identity & classification

GCN Seq No 028226
GCN 07210
HICL code 011931
Ingredient (HICL) Remifentanil Hcl
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H3
Therapeutic class — intermediate (HIC2) Analgesics
HIC3 code H3H
Therapeutic class — specific (HIC3) Opioid Analgesic, Anesthetic Adjunct Agents
AHFS code 28:08.08.00
AHFS class Opioid Agonists (28:08)
FDB label name REMIFENTANIL 5 MG VIAL
FDB brand name Remifentanil Hcl
Legend status F — Federal legend — prescription drug or device
GPI-1465100087102150
GPI classRemifentanil HCl
DEA scheduleCII
Where does this data come from?
Identity codes come from First Databank (FDB) (HICL ingredient, HIC1–3 therapeutic-class hierarchy, GCN, AHFS class, legend status) and Medi-Span GPI, mapped from a representative affected NDC. Licensed reference data — for identification only.

Other analgesia/addiction shortages

Remifentanil Hydrochloride Injection shortage FAQs

Is Remifentanil Hydrochloride Injection in shortage?
Yes — the FDA currently lists Remifentanil Hydrochloride Injection in shortage (status: “Current”, first reported Jun 28, 2022). 9 of 9 products are affected. This is national, manufacturer-reported data, so your pharmacy may still have stock.
Why is Remifentanil Hydrochloride Injection in shortage?
The manufacturer-reported reason on file with the FDA: Demand increase for the drug; Delay in shipping of the drug.
Which products are affected?
Remifentanil Hydrochloride, Injection, 1 mg/1 mL (NDC 63323-725-10) (NDC 63323-0725-10); Remifentanil Hydrochloride, Injection, 1 mg/1 mL (NDC 63323-723-03) (NDC 63323-0723-03); Remifentanil Hydrochloride, Injection, 1 mg/1 mL (NDC 63323-724-05) (NDC 63323-0724-05). The full per-NDC list (availability, manufacturer and status) is in the table above — each NDC links to its own page.
When will Remifentanil Hydrochloride Injection be available again?
The FDA does not publish a guaranteed restock date, and no estimated-recovery note is on file. Availability can change daily — confirm with your pharmacy.
Can I still get Remifentanil Hydrochloride somewhere?
Other manufacturers (Fresenius Kabi USA, LLC, Mylan Institutional LLC) still market it and have not reported a shortage. See “Where else can I get Remifentanil Hydrochloride Injection?” above — stock still varies by pharmacy.
What should I do if I take Remifentanil Hydrochloride Injection?
Don’t stop or change it on your own. Ask your pharmacist whether they can order it from another manufacturer or a different strength/package size, and ask your prescriber about a long-term plan before your supply runs out. Because this is a controlled substance, transfers and substitutions have extra federal/state rules — ask the pharmacy first.

Still have a question about the Remifentanil Hydrochloride Injection shortage?

Ask a pharmacist about this shortage →
How to read the Supply-Risk rating
Low (1–2)Multiple manufacturers still supplying and most strengths or pack sizes sourceable.
Medium (3)Some constraint — fewer suppliers or a notable share of NDCs unavailable.
High (4–5)Down to a single source, most strengths or pack sizes unsourceable, or a long-running outage.
Where does this data come from?
Shortage records come from the FDA Drug Shortages Database API via openFDA (/drug/shortages) — drug, manufacturer & contact, NDC/product, status, availability, reason, therapeutic category and posting/update dates. Current / To Be Discontinued = active; Resolved is kept for history. The Supply-Risk rating is assessed per active ingredient and adds the FDA NDC Directory (still-marketed manufacturers by ingredient & form); same-medicine and equivalent products use First Databank classification + CMS NADAC pricing; Medicaid use + most-affected states come from CMS Medicaid State Drug Utilization Data. Reference only — confirm current status with the manufacturer or FDA before acting on it.
Data structure & sourcing designed and verified by Dr. Brian Staiger, PharmD.
← Back to all current drug shortages