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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

Nortec Development Associates, Inc.

DUNS: 131801359

Effective Date

November 3, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Morphine(100 mg in 1 1)

Manufacturing Establishments7

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

Labeler

Nortec Development Associates, Inc.

DUNS Number

117877975

MPL Laboratories

Labeler

Nortec Development Associates, Inc.

DUNS Number

080265475

Sharp Corporation

Labeler

Nortec Development Associates, Inc.

DUNS Number

143696495

Acta Laboratories, Inc.

Labeler

Nortec Development Associates, Inc.

DUNS Number

804806008

SGS North America Inc.

Labeler

Nortec Development Associates, Inc.

DUNS Number

808308303

Mallinckrodt, Inc.

Labeler

Nortec Development Associates, Inc.

DUNS Number

163205300

Glatt Air Techniques, Inc.

Labeler

Nortec Development Associates, Inc.

DUNS Number

790220628

Products6

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

42689-010

Application Number

ANDA203158

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

November 3, 2023

Ingredients

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

ETHYLCELLULOSE, UNSPECIFIEDInactive

Code: 7Z8S9VYZ4BClass: IACT

METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)Inactive

Code: 74G4R6TH13Class: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

DIETHYL PHTHALATEInactive

Code: UF064M00AFClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

SUCROSEInactive

Code: C151H8M554Class: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UMClass: IACT

FD&C GREEN NO. 3Inactive

Code: 3P3ONR6O1SClass: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8Class: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4TClass: IACT

Code: X3P646A2J0Class: ACTIBQuantity: 100 mg in 1 1

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

Morphine Sulfate

Product Details

NDC Product Code

42689-008

Application Number

ANDA203158

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

November 3, 2023

Ingredients

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)Inactive

Code: 74G4R6TH13Class: IACT

ETHYLCELLULOSE, UNSPECIFIEDInactive

Code: 7Z8S9VYZ4BClass: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

DIETHYL PHTHALATEInactive

Code: UF064M00AFClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

SUCROSEInactive

Code: C151H8M554Class: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UMClass: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOAClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

D&C RED NO. 28Inactive

Code: 767IP0Y5NHClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4TClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

Code: X3P646A2J0Class: ACTIBQuantity: 60 mg in 1 1

Morphine Sulfate

Product Details

NDC Product Code

42689-005

Application Number

ANDA203158

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

November 3, 2023

Ingredients

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

ETHYLCELLULOSE, UNSPECIFIEDInactive

Code: 7Z8S9VYZ4BClass: IACT

METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)Inactive

Code: 74G4R6TH13Class: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

DIETHYL PHTHALATEInactive

Code: UF064M00AFClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UMClass: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

SUCROSEInactive

Code: C151H8M554Class: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4TClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

Code: X3P646A2J0Class: ACTIBQuantity: 20 mg in 1 1

Morphine Sulfate

Product Details

NDC Product Code

42689-007

Application Number

ANDA203158

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

November 3, 2023

Ingredients

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

ETHYLCELLULOSE, UNSPECIFIEDInactive

Code: 7Z8S9VYZ4BClass: IACT

METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)Inactive

Code: 74G4R6TH13Class: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

DIETHYL PHTHALATEInactive

Code: UF064M00AFClass: IACT

SUCROSEInactive

Code: C151H8M554Class: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UMClass: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4TClass: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

Code: X3P646A2J0Class: ACTIBQuantity: 50 mg in 1 1

Morphine Sulfate

Product Details

NDC Product Code

42689-006

Application Number

ANDA203158

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

November 3, 2023

Ingredients

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)Inactive

Code: 74G4R6TH13Class: IACT

ETHYLCELLULOSE, UNSPECIFIEDInactive

Code: 7Z8S9VYZ4BClass: IACT

DIETHYL PHTHALATEInactive

Code: UF064M00AFClass: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

SUCROSEInactive

Code: C151H8M554Class: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UMClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

D&C RED NO. 28Inactive

Code: 767IP0Y5NHClass: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

Code: X3P646A2J0Class: ACTIBQuantity: 30 mg in 1 1

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4TClass: IACT

Morphine Sulfate

Product Details

NDC Product Code

42689-009

Application Number

ANDA203158

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

November 3, 2023

Ingredients

SHELLACInactive

Code: 46N107B71OClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8Class: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4TClass: IACT

Code: X3P646A2J0Class: ACTIBQuantity: 80 mg in 1 1

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)Inactive

Code: 74G4R6TH13Class: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

ETHYLCELLULOSE, UNSPECIFIEDInactive

Code: 7Z8S9VYZ4BClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

DIETHYL PHTHALATEInactive

Code: UF064M00AFClass: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

SUCROSEInactive

Code: C151H8M554Class: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UMClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOAClass: IACT

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