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FDA Approval

Morphine Sulfate

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company

Fresenius Kabi USA, LLC

DUNS: 608775388

Effective Date

February 25, 2021

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Morphine(10 mg in 1 mL)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Fresenius Kabi USA, LLC

Labeler

Fresenius Kabi USA, LLC

DUNS Number

964475045

Products5

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

76045-008

Application Number

NDA204223

Marketing Category

NDA (C73594)

Route of Administration

INTRAVENOUS, INTRAMUSCULAR

Effective Date

August 31, 2020

Ingredients

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACT

TRISODIUM CITRATE DIHYDRATEInactive

Code: B22547B95KClass: IACT

EDETATE DISODIUMInactive

Code: 7FLD91C86KClass: IACT

CITRIC ACID MONOHYDRATEInactive

Code: 2968PHW8QPClass: IACT

CALCIUM CHLORIDEInactive

Code: M4I0D6VV5MClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

Code: X3P646A2J0Class: ACTIBQuantity: 10 mg in 1 mL

Morphine Sulfate

Product Details

NDC Product Code

76045-006

Application Number

NDA204223

Marketing Category

NDA (C73594)

Route of Administration

INTRAVENOUS, INTRAMUSCULAR

Effective Date

August 31, 2020

Ingredients

TRISODIUM CITRATE DIHYDRATEInactive

Code: B22547B95KClass: IACT

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACT

EDETATE DISODIUMInactive

Code: 7FLD91C86KClass: IACT

CALCIUM CHLORIDEInactive

Code: M4I0D6VV5MClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

Code: X3P646A2J0Class: ACTIBQuantity: 5 mg in 1 mL

CITRIC ACID MONOHYDRATEInactive

Code: 2968PHW8QPClass: IACT

Morphine Sulfate

Product Details

NDC Product Code

76045-005

Application Number

NDA204223

Marketing Category

NDA (C73594)

Route of Administration

INTRAVENOUS, INTRAMUSCULAR

Effective Date

August 31, 2020

Ingredients

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACT

CITRIC ACID MONOHYDRATEInactive

Code: 2968PHW8QPClass: IACT

EDETATE DISODIUMInactive

Code: 7FLD91C86KClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

Code: X3P646A2J0Class: ACTIBQuantity: 4 mg in 1 mL

TRISODIUM CITRATE DIHYDRATEInactive

Code: B22547B95KClass: IACT

CALCIUM CHLORIDEInactive

Code: M4I0D6VV5MClass: IACT

Morphine Sulfate

Product Details

NDC Product Code

76045-004

Application Number

NDA204223

Marketing Category

NDA (C73594)

Route of Administration

INTRAVENOUS, INTRAMUSCULAR

Effective Date

August 31, 2020

Ingredients

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACT

TRISODIUM CITRATE DIHYDRATEInactive

Code: B22547B95KClass: IACT

CITRIC ACID MONOHYDRATEInactive

Code: 2968PHW8QPClass: IACT

EDETATE DISODIUMInactive

Code: 7FLD91C86KClass: IACT

CALCIUM CHLORIDEInactive

Code: M4I0D6VV5MClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

Code: X3P646A2J0Class: ACTIBQuantity: 2 mg in 1 mL

Morphine Sulfate

Product Details

NDC Product Code

76045-007

Application Number

NDA204223

Marketing Category

NDA (C73594)

Route of Administration

INTRAVENOUS, INTRAMUSCULAR

Effective Date

August 31, 2020

Ingredients

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACT

CITRIC ACID MONOHYDRATEInactive

Code: 2968PHW8QPClass: IACT

EDETATE DISODIUMInactive

Code: 7FLD91C86KClass: IACT

CALCIUM CHLORIDEInactive

Code: M4I0D6VV5MClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

Code: X3P646A2J0Class: ACTIBQuantity: 8 mg in 1 mL

TRISODIUM CITRATE DIHYDRATEInactive

Code: B22547B95KClass: IACT

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