Morphine Sulfate

Morphine Sulfate Extended-release Capsules, USP Revised: May 2011 CII Rx only 198528

Approved

Approval ID

bcb37ca5-9406-4e5a-bcd4-7e737e403c33

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Feb 19, 2015

Manufacturers

FDA

Par Pharmaceutical Inc.

DUNS: 092733690

Products 6

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Morphine Sulfate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code49884-670

Application NumberANDA200812

Product Classification

Marketing Category

C73584

Generic Name

Morphine Sulfate

Product Specifications

Route of AdministrationORAL

Effective DateFebruary 19, 2015

FDA Product Classification

INGREDIENTS (19)

POLYETHYLENE GLYCOL 6000Inactive

Code: 30IQX730WE

Classification: IACT

ETHYLCELLULOSESInactive

Code: 7Z8S9VYZ4B

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

POVIDONE K30Inactive

Code: U725QWY32X

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3G

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

MORPHINE SULFATEActive

Quantity: 100 mg in 1 1

Code: X3P646A2J0

Classification: ACTIB

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

DIETHYL PHTHALATEInactive

Code: UF064M00AF

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOA

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FD&C GREEN NO. 3Inactive

Code: 3P3ONR6O1S

Classification: IACT

HYPROMELLOSE 2910 (5 MPA.S)Inactive

Code: R75537T0T4

Classification: IACT

METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive

Code: NX76LV5T8J

Classification: IACT

Morphine Sulfate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code49884-668

Application NumberANDA200812

Product Classification

Marketing Category

C73584

Generic Name

Morphine Sulfate

Product Specifications

Route of AdministrationORAL

Effective DateFebruary 19, 2015

FDA Product Classification

INGREDIENTS (17)

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

MORPHINE SULFATEActive

Quantity: 60 mg in 1 1

Code: X3P646A2J0

Classification: ACTIB

DIETHYL PHTHALATEInactive

Code: UF064M00AF

Classification: IACT

ETHYLCELLULOSESInactive

Code: 7Z8S9VYZ4B

Classification: IACT

POLYETHYLENE GLYCOL 6000Inactive

Code: 30IQX730WE

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

POVIDONE K30Inactive

Code: U725QWY32X

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOA

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

D&C RED NO. 28Inactive

Code: 767IP0Y5NH

Classification: IACT

HYPROMELLOSE 2910 (5 MPA.S)Inactive

Code: R75537T0T4

Classification: IACT

METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive

Code: NX76LV5T8J

Classification: IACT

Morphine Sulfate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code49884-667

Application NumberANDA200812

Product Classification

Marketing Category

C73584

Generic Name

Morphine Sulfate

Product Specifications

Route of AdministrationORAL

Effective DateFebruary 19, 2015

FDA Product Classification

INGREDIENTS (15)

POLYETHYLENE GLYCOL 6000Inactive

Code: 30IQX730WE

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

MORPHINE SULFATEActive

Quantity: 50 mg in 1 1

Code: X3P646A2J0

Classification: ACTIB

ETHYLCELLULOSESInactive

Code: 7Z8S9VYZ4B

Classification: IACT

DIETHYL PHTHALATEInactive

Code: UF064M00AF

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

POVIDONE K30Inactive

Code: U725QWY32X

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

HYPROMELLOSE 2910 (5 MPA.S)Inactive

Code: R75537T0T4

Classification: IACT

METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive

Code: NX76LV5T8J

Classification: IACT

Morphine Sulfate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code49884-665

Application NumberANDA200812

Product Classification

Marketing Category

C73584

Generic Name

Morphine Sulfate

Product Specifications

Route of AdministrationORAL

Effective DateFebruary 19, 2015

FDA Product Classification

INGREDIENTS (15)

HYPROMELLOSE 2910 (5 MPA.S)Inactive

Code: R75537T0T4

Classification: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3G

Classification: IACT

MORPHINE SULFATEActive

Quantity: 20 mg in 1 1

Code: X3P646A2J0

Classification: ACTIB

DIETHYL PHTHALATEInactive

Code: UF064M00AF

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

ETHYLCELLULOSESInactive

Code: 7Z8S9VYZ4B

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive

Code: NX76LV5T8J

Classification: IACT

POLYETHYLENE GLYCOL 6000Inactive

Code: 30IQX730WE

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

POVIDONE K30Inactive

Code: U725QWY32X

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

Morphine Sulfate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code49884-666

Application NumberANDA200812

Product Classification

Marketing Category

C73584

Generic Name

Morphine Sulfate

Product Specifications

Route of AdministrationORAL

Effective DateFebruary 19, 2015

FDA Product Classification

INGREDIENTS (16)

MORPHINE SULFATEActive

Quantity: 30 mg in 1 1

Code: X3P646A2J0

Classification: ACTIB

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

DIETHYL PHTHALATEInactive

Code: UF064M00AF

Classification: IACT

ETHYLCELLULOSESInactive

Code: 7Z8S9VYZ4B

Classification: IACT

POLYETHYLENE GLYCOL 6000Inactive

Code: 30IQX730WE

Classification: IACT

POVIDONE K30Inactive

Code: U725QWY32X

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive

Code: NX76LV5T8J

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

FD&C RED NO. 3Inactive

Code: PN2ZH5LOQY

Classification: IACT

HYPROMELLOSE 2910 (5 MPA.S)Inactive

Code: R75537T0T4

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

Morphine Sulfate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code49884-669

Application NumberANDA200812

Product Classification

Marketing Category

C73584

Generic Name

Morphine Sulfate

Product Specifications

Route of AdministrationORAL

Effective DateFebruary 19, 2015

FDA Product Classification

INGREDIENTS (19)

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

DIETHYL PHTHALATEInactive

Code: UF064M00AF

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

HYPROMELLOSE 2910 (5 MPA.S)Inactive

Code: R75537T0T4

Classification: IACT

POLYETHYLENE GLYCOL 6000Inactive

Code: 30IQX730WE

Classification: IACT

ETHYLCELLULOSESInactive

Code: 7Z8S9VYZ4B

Classification: IACT

POVIDONE K30Inactive

Code: U725QWY32X

Classification: IACT

MORPHINE SULFATEActive

Quantity: 80 mg in 1 1

Code: X3P646A2J0

Classification: ACTIB

SUCROSEInactive

Code: C151H8M554

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3G

Classification: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOA

Classification: IACT

METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive

Code: NX76LV5T8J

Classification: IACT

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Morphine Sulfate

Products 6

Morphine Sulfate

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (19)

Morphine Sulfate

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (17)

Morphine Sulfate

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (15)

Morphine Sulfate

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (15)

Morphine Sulfate

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (16)

Morphine Sulfate

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (19)

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