FDA label
What is remifentanil used for?
The FDA-approved uses of remifentanil, quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label says: “Remifentanil hydrochloride (HCl) for injection is indicated for intravenous (IV) administration: As an analgesic agent for use during the induction and maintenance of general anesthesia for inpatient and outpatient procedures; For continuation as an analgesic into the immediate postoperative period in adult patients under the direct supervision of an anesthesia practitioner in a postoperative a...”
Run it in Rivvi
Which 2027 plans near you dropped or restricted remifentanil?
Tier changes and new prior auth, step therapy or quantity limits, plan by plan.
Free to start. Opens Rivvi, the AI workspace for healthcare teams.
Remifentanil Hydrochloride, injection, powder, lyophilized, for solution
Indications and Usage, quoted from the label by Fresenius Kabi USA, LLC (ANDA206223). Cross-references to other label sections are left out.
Remifentanil hydrochloride (HCl) for injection is indicated for intravenous (IV) administration:
- As an analgesic agent for use during the induction and maintenance of general anesthesia for inpatient and outpatient procedures.
- For continuation as an analgesic into the immediate postoperative period in adult patients under the direct supervision of an anesthesia practitioner in a postoperative anesthesia care unit or intensive care setting.
- As an analgesic component of monitored anesthesia care in adult patients.
Source: DailyMed label, set id 5b8025d2-3424-477b-9cff-3990a98c2a65, version 3, effective February 13, 2025. NDC 63323-723, one of 7 listings for this product.
Questions
What is remifentanil used for?
The FDA label says: “Remifentanil hydrochloride (HCl) for injection is indicated for intravenous (IV) administration: As an analgesic agent for use during the induction and maintenance of general anesthesia for inpatient and outpatient procedures; For continuation as an analgesic into the immediate postoperative period in adult patients under the direct supervision of an anesthesia practitioner in a postoperative a...”
What drug class is remifentanil?
FDA lists remifentanil in the Opioid Agonist established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.
More on Remifentanil
- Is Remifentanil a controlled substance?Schedule II
- Generic for UltivaFDA Orange Book
- What is Ultiva used for?FDA label uses
- Is Ultiva a controlled substance?Schedule II
- Opioid Agonists listFDA drug class
- NDC 67457-912Remifentanil NDC record
- NDC 67457-913Remifentanil NDC record
- NDC 67457-914Remifentanil NDC record
- Schedule II drugs listDEA schedule