Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Fresenius Kabi USA, LLC
Fresenius Kabi USA, LLC
964475045
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
63323-808Application Number
ANDA212086Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUS, INTRAMUSCULAREffective Date
January 31, 2023WaterInactive
Code: 059QF0KO0RClass: IACT
FentanylActive
Code: MUN5LYG46HClass: ACTIMQuantity: 50 ug in 1 mL
Hydrochloric AcidInactive
Code: QTT17582CBClass: IACT
Sodium HydroxideInactive
Code: 55X04QC32IClass: IACT
Fentanyl Citrate
Product Details
NDC Product Code
63323-810Application Number
ANDA212086Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUS, INTRAMUSCULAREffective Date
January 31, 2023Hydrochloric AcidInactive
Code: QTT17582CBClass: IACT
FentanylActive
Code: MUN5LYG46HClass: ACTIMQuantity: 100 ug in 2 mL
Sodium HydroxideInactive
Code: 55X04QC32IClass: IACT
WaterInactive
Code: 059QF0KO0RClass: IACT