Active ingredient
Fentanyl
54 finished FDA listings contain Fentanyl as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- FENTANYL, FENTANYL CITRATE, FENTANYL HYDROCHLORIDE
- Dosage forms
- Injection, Injection, Solution, Patch, Patch, Extended Release
- Routes
- Intramuscular, Intravenous, Transdermal
- Manufacturers / labelers
- 10
- Strengths listed
- .05 mg/ml · 100 ug/1 · 100 ug/2ml · 100 ug/h · 12 ug/h · 12.5 ug/1 · 12.5 ug/h · 25 ug/1 · 25 ug/h · 37.5 ug/h · 50 ug/1 · 50 ug/h · 50 ug/ml · 62.5 ug/h · 75 ug/1 · 75 ug/h · 87.5 ug/h
- Brand names in FDA listings
- Fentanyl System
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 4337
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 019101 | HIKMA | 1984-07-11 | 13 |
| NDA 019115 | HOSPIRA | 1985-01-12 | 2 |
| ANDA 076258 | MYLAN TECHNOLOGIES | 2005-01-28 | 8 |
| ANDA 077449 | DIFGEN PHARMS | 2008-10-20 | 16 |
| ANDA 077154 | SPECGX LLC | 2011-02-09 | 7 |
| ANDA 202097 | KINDEVA | 2016-11-04 | 5 |
| ANDA 210762 | FRESENIUS KABI USA | 2019-05-03 | 1 |
| ANDA 212086 | FRESENIUS KABI USA | 2020-09-01 | 2 |
Official labeling on DailyMed
- FENTANYL CITRATE INJECTION, SOLUTION [HOSPIRA, INC.] · version 35 · 2026-08-25
- FENTANYL TRANSDERMAL PATCH, EXTENDED RELEASE [SPECGX LLC] · version 58 · 2026-05-06
- FENTANYL CITRATE INJECTION, SOLUTION [HOSPIRA, INC.] · version 17 · 2026-04-10
- FENTANYL PATCH, EXTENDED RELEASE [AVEVA DRUG DELIVERY SYSTEMS INC.] · version 2 · 2026-04-08
- FENTANYL PATCH, EXTENDED RELEASE [INGENUS PHARMACEUTICALS, LLC] · version 6 · 2026-04-08
- FENTANYL CITRATE INJECTION [CIVICA, INC.] · version 13 · 2026-03-30
- FENTANYL CITRATE INJECTION [PHLOW CORP.] · version 10 · 2026-03-25
- FENTANYL CITRATE INJECTION [HIKMA PHARMACEUTICALS USA INC.] · version 18 · 2026-03-20
- FENTANYL SYSTEM (FENTANYL) PATCH [ALVOGEN] · version 27 · 2026-03-04
- FENTANYL PATCH [MYLAN PHARMACEUTICALS INC.] · version 27 · 2026-02-25
- FENTANYL CITRATE INJECTION [HIKMA PHARMACEUTICALS USA INC.] · version 3 · 2026-02-23
- FENTANYL CITRATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] · version 6 · 2025-11-21
Showing the 12 most recent of 13 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.