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FDA Approval

Morphine Sulfate

CompanyFresenius Kabi, USA LLC (DUNS: 608775388)

Effective Date

January 1, 2024

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Morphine(5 mg in 1 mL)

Manufacturing Establishments (1)

Fresenius Kabi, USA LLC

Labeler

Fresenius Kabi, USA LLC

DUNS Number

964475045

Products (5)

Morphine Sulfate

NDC Product Code

76045-006

Application Number

NDA204223

Marketing Category

NDA (C73594)

Route of Administration

INTRAVENOUS, INTRAMUSCULAR

Effective Date

August 10, 2018

Ingredients

Code: X3P646A2J0Class: ACTIBQuantity: 5 mg in 1 mL

Sodium chlorideInactive

Code: 451W47IQ8XClass: IACT

Citric Acid MonohydrateInactive

Code: 2968PHW8QPClass: IACT

Trisodium Citrate DihydrateInactive

Code: B22547B95KClass: IACT

Edetate DisodiumInactive

Code: 7FLD91C86KClass: IACT

Calcium ChlorideInactive

Code: M4I0D6VV5MClass: IACT

WaterInactive

Code: 059QF0KO0RClass: IACT

Morphine Sulfate

NDC Product Code

76045-007

Application Number

NDA204223

Marketing Category

NDA (C73594)

Route of Administration

INTRAVENOUS, INTRAMUSCULAR

Effective Date

August 10, 2018

Ingredients

Code: X3P646A2J0Class: ACTIBQuantity: 8 mg in 1 mL

Sodium chlorideInactive

Code: 451W47IQ8XClass: IACT

Citric Acid MonohydrateInactive

Code: 2968PHW8QPClass: IACT

Edetate DisodiumInactive

Code: 7FLD91C86KClass: IACT

Calcium ChlorideInactive

Code: M4I0D6VV5MClass: IACT

Trisodium Citrate DihydrateInactive

Code: B22547B95KClass: IACT

WaterInactive

Code: 059QF0KO0RClass: IACT

Morphine Sulfate

NDC Product Code

76045-005

Application Number

NDA204223

Marketing Category

NDA (C73594)

Route of Administration

INTRAVENOUS, INTRAMUSCULAR

Effective Date

August 10, 2018

Ingredients

Code: X3P646A2J0Class: ACTIBQuantity: 4 mg in 1 mL

Trisodium Citrate DihydrateInactive

Code: B22547B95KClass: IACT

Citric Acid MonohydrateInactive

Code: 2968PHW8QPClass: IACT

Calcium ChlorideInactive

Code: M4I0D6VV5MClass: IACT

Edetate DisodiumInactive

Code: 7FLD91C86KClass: IACT

Sodium chlorideInactive

Code: 451W47IQ8XClass: IACT

WaterInactive

Code: 059QF0KO0RClass: IACT

Morphine Sulfate

NDC Product Code

76045-004

Application Number

NDA204223

Marketing Category

NDA (C73594)

Route of Administration

INTRAVENOUS, INTRAMUSCULAR

Effective Date

August 10, 2018

Ingredients

Sodium chlorideInactive

Code: 451W47IQ8XClass: IACT

WaterInactive

Code: 059QF0KO0RClass: IACT

Code: X3P646A2J0Class: ACTIBQuantity: 2 mg in 1 mL

Trisodium Citrate DihydrateInactive

Code: B22547B95KClass: IACT

Citric Acid MonohydrateInactive

Code: 2968PHW8QPClass: IACT

Edetate DisodiumInactive

Code: 7FLD91C86KClass: IACT

Calcium ChlorideInactive

Code: M4I0D6VV5MClass: IACT

Morphine Sulfate

NDC Product Code

76045-008

Application Number

NDA204223

Marketing Category

NDA (C73594)

Route of Administration

INTRAVENOUS, INTRAMUSCULAR

Effective Date

August 10, 2018

Ingredients

Trisodium Citrate DihydrateInactive

Code: B22547B95KClass: IACT

Citric Acid MonohydrateInactive

Code: 2968PHW8QPClass: IACT

Code: X3P646A2J0Class: ACTIBQuantity: 10 mg in 1 mL

Sodium chlorideInactive

Code: 451W47IQ8XClass: IACT

Edetate DisodiumInactive

Code: 7FLD91C86KClass: IACT

Calcium ChlorideInactive

Code: M4I0D6VV5MClass: IACT

WaterInactive

Code: 059QF0KO0RClass: IACT

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