FENTANYL CITRATE - Food and Drug Administration

Manufacturer: Food and Drug Administration
Effective date: 2016-01-04
Label type: Indexing - Product Concept
Version: 2
Source: full-release
Hydrated at: 2026-06-05 00:16:22

Label at a glance#

ProductFENTANYL CITRATE

Active ingredientFENTANYL CITRATE

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 2 matching rows.

FENTANYL CITRATE
FENTANYL

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
FENTANYL CITRATE	MUN5LYG46H	ACTIM
FENTANYL CITRATE	MUN5LYG46H	ACTIM
FENTANYL CITRATE	MUN5LYG46H	ACTIM

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fentanyl Citrate	FENTANYL CITRATE	Hospira, Inc.	bfa8018a-4cbc-434b-e09e-782872b0340a	2026-08-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Fentanyl Citrate generic name: FENTANYL CITRATE
FENTANYL CITRATE	FENTANYL CITRATE	Hospira, Inc.	1ed25b2c-334e-4021-ada1-3396f07630dc	2026-04-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: FENTANYL CITRATE generic name: FENTANYL CITRATE
Fentanyl Citrate	FENTANYL CITRATE	Hikma Pharmaceuticals USA Inc.	ce5db1c2-feb1-4ad2-847a-d02e865bd47e	2026-03-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Fentanyl Citrate generic name: FENTANYL CITRATE
Fentanyl Citrate	FENTANYL CITRATE	Civica, Inc.	aacf276b-e133-4199-ad3f-67b894744c04	2025-12-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Fentanyl Citrate generic name: FENTANYL CITRATE
Fentanyl Citrate	FENTANYL CITRATE	Phlow Corp.	58dcd3f7-e3d8-4929-a186-8f680a51ff11	2025-12-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Fentanyl Citrate generic name: FENTANYL CITRATE
Fentanyl Citrate	FENTANYL CITRATE	Hikma Pharmaceuticals USA Inc.	c5fcdcbd-1dd1-4ebf-aa0d-edfe845414b7	2025-12-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Fentanyl Citrate generic name: FENTANYL CITRATE
Fentanyl Citrate	FENTANYL CITRATE	Fresenius Kabi USA, LLC	0c10e465-4117-48ba-a454-23ccb7a3fcc7	2025-09-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Fentanyl Citrate generic name: FENTANYL CITRATE
Fentanyl Citrate	FENTANYL CITRATE	Fresenius Kabi USA, LLC	38d0c14a-a0c1-44cc-a939-0304eb8037d6	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Fentanyl Citrate generic name: FENTANYL CITRATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.