Active ingredient
Remifentanil
13 finished FDA listings contain Remifentanil as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- REMIFENTANIL HYDROCHLORIDE
- Dosage forms
- Injection, Powder, Lyophilized, For Solution
- Routes
- Intravenous
- Manufacturers / labelers
- 3
- Strengths listed
- 1 mg/ml · 2 mg/2ml · 5 mg/5ml
- Brand names in FDA listings
- Ultiva
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 73032
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 020630 | MYLAN INSTITUTIONAL | 1996-07-12 | 6 |
| ANDA 206223 | FRESENIUS KABI USA | 2018-01-16 | 4 |
| ANDA 210594 | HIKMA | 2020-10-13 | 3 |
Official labeling on DailyMed
- ULTIVA (REMIFENTANIL HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MYLAN INSTITUTIONAL LLC] · version 5 · 2026-08-20
- ULTIVA (REMIFENTANIL HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MYLAN INSTITUTIONAL LLC] · version 6 · 2026-08-17
- REMIFENTANIL HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] · version 3 · 2025-03-10
- REMIFENTANIL HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] · version 6 · 2024-10-28
- REMIFENTANIL HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.] · version 4 · 2024-03-12
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.