Metoprolol Succinate

These highlights do not include all the information needed to use METOPROLOL SUCCINATE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for METOPROLOL SUCCINATE EXTENDED-RELEASE CAPSULES.METOPROLOL SUCCINATE extended-release capsules, for oral useInitial U.S. Approval: 1992

Approved

Approval ID

90aa06a3-100f-4466-b950-506303707b01

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Feb 7, 2018

Manufacturers

FDA

Sun Pharmaceutical Industries Inc.

DUNS: 146974886

Products 4

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

Metoprolol Succinate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code63304-011

Application NumberNDA210428

Product Classification

Marketing Category

C73594

Generic Name

Metoprolol Succinate

Product Specifications

Route of AdministrationORAL

Effective DateFebruary 7, 2018

FDA Product Classification

INGREDIENTS (16)

METOPROLOL SUCCINATEActive

Quantity: 200 mg in 1 1

Code: TH25PD4CCB

Classification: ACTIR

ETHYLCELLULOSE (20 MPA.S)Inactive

Code: BJG0S321QY

Classification: IACT

HYPROMELLOSE 2910 (5 MPA.S)Inactive

Code: R75537T0T4

Classification: IACT

POLYETHYLENE GLYCOL 400Inactive

Code: B697894SGQ

Classification: IACT

POLYETHYLENE GLYCOL 6000Inactive

Code: 30IQX730WE

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4T

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

Metoprolol Succinate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code63304-008

Application NumberNDA210428

Product Classification

Marketing Category

C73594

Generic Name

Metoprolol Succinate

Product Specifications

Route of AdministrationORAL

Effective DateFebruary 7, 2018

FDA Product Classification

INGREDIENTS (16)

HYPROMELLOSE 2910 (5 MPA.S)Inactive

Code: R75537T0T4

Classification: IACT

METOPROLOL SUCCINATEActive

Quantity: 25 mg in 1 1

Code: TH25PD4CCB

Classification: ACTIR

POLYETHYLENE GLYCOL 400Inactive

Code: B697894SGQ

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4T

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

ETHYLCELLULOSE (20 MPA.S)Inactive

Code: BJG0S321QY

Classification: IACT

POLYETHYLENE GLYCOL 6000Inactive

Code: 30IQX730WE

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

Metoprolol Succinate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code63304-010

Application NumberNDA210428

Product Classification

Marketing Category

C73594

Generic Name

Metoprolol Succinate

Product Specifications

Route of AdministrationORAL

Effective DateFebruary 7, 2018

FDA Product Classification

INGREDIENTS (15)

METOPROLOL SUCCINATEActive

Quantity: 100 mg in 1 1

Code: TH25PD4CCB

Classification: ACTIR

HYPROMELLOSE 2910 (5 MPA.S)Inactive

Code: R75537T0T4

Classification: IACT

ETHYLCELLULOSE (20 MPA.S)Inactive

Code: BJG0S321QY

Classification: IACT

POLYETHYLENE GLYCOL 400Inactive

Code: B697894SGQ

Classification: IACT

POLYETHYLENE GLYCOL 6000Inactive

Code: 30IQX730WE

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4T

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

Metoprolol Succinate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code63304-009

Application NumberNDA210428

Product Classification

Marketing Category

C73594

Generic Name

Metoprolol Succinate

Product Specifications

Route of AdministrationORAL

Effective DateFebruary 7, 2018

FDA Product Classification

INGREDIENTS (16)

METOPROLOL SUCCINATEActive

Quantity: 50 mg in 1 1

Code: TH25PD4CCB

Classification: ACTIR

HYPROMELLOSE 2910 (5 MPA.S)Inactive

Code: R75537T0T4

Classification: IACT

POLYETHYLENE GLYCOL 400Inactive

Code: B697894SGQ

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

POLYETHYLENE GLYCOL 6000Inactive

Code: 30IQX730WE

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4T

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

ETHYLCELLULOSE (20 MPA.S)Inactive

Code: BJG0S321QY

Classification: IACT

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Metoprolol Succinate

Products 4

Metoprolol Succinate

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (16)

Metoprolol Succinate

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (16)

Metoprolol Succinate

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (15)

Metoprolol Succinate

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (16)

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