Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Exela Pharma Sciences, LLC
Exela Pharma Sciences, LLC
831274399
Products2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Fentanyl Citrate
Product Details
NDC Product Code
51754-2150Application Number
NDA215870Marketing Category
NDA (C73594)Route of Administration
INTRAVENOUSEffective Date
December 18, 2023FentanylActive
Code: MUN5LYG46HClass: ACTIMQuantity: 50 ug in 1 mL
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
Fentanyl Citrate
Product Details
NDC Product Code
51754-2160Application Number
NDA215870Marketing Category
NDA (C73594)Route of Administration
INTRAVENOUSEffective Date
December 18, 2023FentanylActive
Code: MUN5LYG46HClass: ACTIMQuantity: 50 ug in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT