Manufacturing Establishments2
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Hospira, Inc.
Hospira, Inc.
827731089
Hospira Worldwide, LLC
Hospira, Inc.
963711309
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
0409-9093Application Number
NDA019115Marketing Category
NDA (C73594)Route of Administration
INTRAVENOUS, INTRAMUSCULAREffective Date
December 11, 2019FentanylActive
Code: MUN5LYG46HClass: ACTIMQuantity: 50 ug in 1 mL
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
FENTANYL CITRATE
Product Details
NDC Product Code
0409-9094Application Number
NDA019115Marketing Category
NDA (C73594)Route of Administration
INTRAVENOUS, INTRAMUSCULAREffective Date
December 11, 2019FentanylActive
Code: MUN5LYG46HClass: ACTIMQuantity: 50 ug in 1 mL
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT