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 use, CII.Initial U.S. Approval: 1968.
Approved
Approval ID
c94b4a5e-4224-4d0b-a0f8-371fba043ebe
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 18, 2023
Manufacturers
FDA
Exela Pharma Sciences, LLC
DUNS: 831274399
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 Code51754-2150
Application NumberNDA215870
Product Classification
M
Marketing Category
C73594
G
Generic Name
Fentanyl Citrate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 18, 2023
FDA Product Classification
INGREDIENTS (4)
FENTANYL CITRATEActive
Quantity: 50 ug in 1 mL
Code: MUN5LYG46H
Classification: ACTIM
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
Fentanyl Citrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51754-2160
Application NumberNDA215870
Product Classification
M
Marketing Category
C73594
G
Generic Name
Fentanyl Citrate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 18, 2023
FDA Product Classification
INGREDIENTS (4)
FENTANYL CITRATEActive
Quantity: 50 ug in 1 mL
Code: MUN5LYG46H
Classification: ACTIM
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT