Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Hospira, Inc.
Hospira, Inc.
827731089
Products2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Morphine sulfate
Product Details
NDC Product Code
0409-2022Application Number
NDA202515Marketing Category
NDA (C73594)Route of Administration
INTRAVENOUSEffective Date
December 28, 2023EDETATE DISODIUMInactive
Code: 7FLD91C86KClass: IACTQuantity: 0.2 mg in 1 mL
MorphineActive
Code: X3P646A2J0Class: ACTIBQuantity: 50 mg in 1 mL
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACTQuantity: 0.8 mg in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
Morphine Sulfate
Product Details
NDC Product Code
0409-1896Application Number
NDA202515Marketing Category
NDA (C73594)Route of Administration
INTRAVENOUSEffective Date
December 28, 2023MorphineActive
Code: X3P646A2J0Class: ACTIBQuantity: 50 mg in 1 mL
EDETATE DISODIUMInactive
Code: 7FLD91C86KClass: IACTQuantity: 0.2 mg in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACTQuantity: 0.8 mg in 1 mL
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT