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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

Hikma Pharmaceuticals USA Inc.

DUNS: 080189610

Effective Date

November 15, 2024

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Morphine(100 mg in 5 mL)

Manufacturing Establishments1

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

West-Ward Columbus Inc.

Labeler

Hikma Pharmaceuticals USA Inc.

DUNS Number

058839929

Products4

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

0054-0404

Application Number

NDA022195

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

November 15, 2024

Ingredients

Code: X3P646A2J0Class: ACTIBQuantity: 100 mg in 5 mL

CITRIC ACID MONOHYDRATEInactive

Code: 2968PHW8QPClass: IACT

EDETATE DISODIUMInactive

Code: 7FLD91C86KClass: IACT

GLYCERINInactive

Code: PDC6A3C0OXClass: IACT

SORBITOLInactive

Code: 506T60A25RClass: IACT

SODIUM BENZOATEInactive

Code: OJ245FE5EUClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

Morphine Sulfate

Product Details

NDC Product Code

0054-0517

Application Number

NDA022195

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

November 15, 2024

Ingredients

GLYCERINInactive

Code: PDC6A3C0OXClass: IACT

EDETATE DISODIUMInactive

Code: 7FLD91C86KClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

SUCRALOSEInactive

Code: 96K6UQ3ZD4Class: IACT

D&C RED NO. 33Inactive

Code: 9DBA0SBB0LClass: IACT

Code: X3P646A2J0Class: ACTIBQuantity: 100 mg in 5 mL

CITRIC ACID MONOHYDRATEInactive

Code: 2968PHW8QPClass: IACT

SODIUM BENZOATEInactive

Code: OJ245FE5EUClass: IACT

SORBITOLInactive

Code: 506T60A25RClass: IACT

Morphine Sulfate

Product Details

NDC Product Code

0054-0237

Application Number

NDA022195

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

November 15, 2024

Ingredients

CITRIC ACID MONOHYDRATEInactive

Code: 2968PHW8QPClass: IACT

FD&C GREEN NO. 3Inactive

Code: 3P3ONR6O1SClass: IACT

Code: X3P646A2J0Class: ACTIBQuantity: 10 mg in 5 mL

GLYCERINInactive

Code: PDC6A3C0OXClass: IACT

EDETATE DISODIUMInactive

Code: 7FLD91C86KClass: IACT

SORBITOLInactive

Code: 506T60A25RClass: IACT

SODIUM BENZOATEInactive

Code: OJ245FE5EUClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

Morphine Sulfate

Product Details

NDC Product Code

0054-0238

Application Number

NDA022195

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

November 15, 2024

Ingredients

EDETATE DISODIUMInactive

Code: 7FLD91C86KClass: IACT

PROPYLPARABENInactive

Code: Z8IX2SC1OHClass: IACT

SODIUM BENZOATEInactive

Code: OJ245FE5EUClass: IACT

SORBITOLInactive

Code: 506T60A25RClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

Code: X3P646A2J0Class: ACTIBQuantity: 20 mg in 5 mL

CITRIC ACID MONOHYDRATEInactive

Code: 2968PHW8QPClass: IACT

FD&C GREEN NO. 3Inactive

Code: 3P3ONR6O1SClass: IACT

GLYCERINInactive

Code: PDC6A3C0OXClass: IACT

METHYLPARABENInactive

Code: A2I8C7HI9TClass: IACT

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