Fentanyl Citrate
These highlights do not include all the information needed to use FENTANYL CITRATE INJECTION safely and effectively. See full prescribing information for FENTANYL CITRATE INJECTION.FENTANYL CITRATE injection, for intravenous or intramuscular use, CIIInitial U.S. Approval: 1968
Approved
Approval ID
0c10e465-4117-48ba-a454-23ccb7a3fcc7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 5, 2024
Manufacturers
FDA
Fresenius Kabi USA, LLC
DUNS: 608775388
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Fentanyl Citrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63323-808
Application NumberANDA212086
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fentanyl Citrate
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateJanuary 31, 2023
FDA Product Classification
INGREDIENTS (4)
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Fentanyl CitrateActive
Quantity: 50 ug in 1 mL
Code: MUN5LYG46H
Classification: ACTIM
Hydrochloric AcidInactive
Code: QTT17582CB
Classification: IACT
Sodium HydroxideInactive
Code: 55X04QC32I
Classification: IACT
Fentanyl Citrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63323-810
Application NumberANDA212086
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fentanyl Citrate
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateJanuary 31, 2023
FDA Product Classification
INGREDIENTS (4)
Hydrochloric AcidInactive
Code: QTT17582CB
Classification: IACT
Fentanyl CitrateActive
Quantity: 100 ug in 2 mL
Code: MUN5LYG46H
Classification: ACTIM
Sodium HydroxideInactive
Code: 55X04QC32I
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT