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Sold as Sublimaze Preservative Free, Fentanyl Citrate, Fentanyl, Actiq, Fentora and 3 more. Every FDA application for this active ingredient: 10 branded and 12 generic.
As of Nov 14, 2026, FDA lists 22 applications for Fentanyl Citrate (sold as Sublimaze Preservative Free, Fentanyl Citrate, Fentanyl and others), first approved Feb 19, 1968, with 4 new uses approved and 0 published complete response letters.
First approved: Feb 19, 1968
Applications: 22
New uses approved: 4
Complete response letters: 0
Medicare spending, 2025: $91K
First approved in the EU: Jan 24, 2006
Shortage: Current
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
Fentanyl Citrate
Part D
$91K
-90%
15,764
Fentora
Part D
$0K
-100%
0
What Pharmacies Pay
Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change
FENTANYL 100 MCG/2 ML VIAL: $1.76 per MLGeneric · +52% in a year
FENTANYL 100 MCG/HR PATCH: $19.62 per unitGeneric · +10% in a year
FENTANYL 12 MCG/HR PATCH: $9.37 per unitGeneric · +3% in a year
FENTANYL 2,500 MCG/50 ML VIAL: $1.76 per MLGeneric · +52% in a year
FENTANYL 25 MCG/HR PATCH: $6.07 per unitGeneric · +9% in a year
FENTANYL 250 MCG/5 ML VIAL: $1.76 per MLGeneric · +52% in a year
FENTANYL 37.5 MCG/HR PATCH: $36.19 per unitGeneric · -15% in a year
FENTANYL 50 MCG/HR PATCH: $9.07 per unitGeneric · -5% in a year
FENTANYL 62.5 MCG/HR PATCH: $57.69 per unitGeneric · new this year
FENTANYL 75 MCG/HR PATCH: $15.80 per unitGeneric · +16% in a year
FentosDrugs with a new indication and a new additional pediatric dosage for the analgesia in various types of cancer with moderate to severe pain that cannot be… · Hisamitsu Pharmaceutical Co., Inc. · Aug 25, 2021
FentosDrugs with a new indication and a new dosage for the analgesia in various types of cancer with moderate to severe pain that cannot be managed with… · Hisamitsu Pharmaceutical Co., Inc. · Jun 29, 2020
Lafenta, new approvalDrugs in a new dosage form indicated for analgesia in various types of cancer with moderate to severe pain that cannot be managed with non- opioid… · Nippon Zoki Pharmaceutical Co., Ltd. · Mar 26, 2019
Fentos, new approvalDrugs with a new dosage and in additional dosage form indicated for: (1) analgesia in various types of cancer with moderate to severe pain that cannot be… · Hisamitsu Pharmaceutical Co., Inc. · Jul 2, 2018
FentosDrugs with a new indication for analgesia in moderate to severe chronic pain which cannot be managed by treatments with non-opioid analgesics and weak… · Hisamitsu Pharmaceutical Co., Inc. · Jun 20, 2014
OneDuroDrugs with a new additional indication for analgesia in moderate to severe chronic pain which cannot be managed by treatments with non-opioid analgesics and… · Janssen Pharmaceutical K.K. · Dec 20, 2013
Abstral Sublingual, new approvalDrugs with a new dosage in a new dosage form indicated for analgesia of breakthrough pain in patients with cancer receiving a potent opioid analgesic at… · Kyowa Hakko Kirin Co., Ltd. · Sep 20, 2013
E-fen Buccal, new approvalDrugs with a new dosage in a new dosage form for the analgesia of breakthrough pain in patients with cancer receiving a potent opioid analgesic at a fixed time. · Teikoku Seiyaku Co., Ltd. · Jun 28, 2013
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient.Drugs@FDA
Hikma
Abbott
Par Pharm
Fresenius Kabi USA