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TOPROL XL

These highlights do not include all the information needed to use TOPROL-XL safely and effectively. See full prescribing information for TOPROL-XL. TOPROL-XL (metoprolol succinate) Tablet, Extended-Release for Oral Use Initial U.S. Approval: 1992

Approved
Approval ID

496ddfaa-7c9c-4888-b747-a210249b367a

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 28, 2022

Manufacturers
FDA

Melinta Therapeutics, LLC

DUNS: 079949853

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 Code70842-113
Application NumberNDA019962
Product Classification
M
Marketing Category
C73594
G
Generic Name
Metoprolol Succinate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 28, 2022
FDA Product Classification

INGREDIENTS (7)

TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
METOPROLOL SUCCINATEActive
Quantity: 200 mg in 1 1
Code: TH25PD4CCB
Classification: ACTIR
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
PARAFFINInactive
Code: I9O0E3H2ZE
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT

Metoprolol Succinate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code70842-111
Application NumberNDA019962
Product Classification
M
Marketing Category
C73594
G
Generic Name
Metoprolol Succinate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 28, 2022
FDA Product Classification

INGREDIENTS (7)

METOPROLOL SUCCINATEActive
Quantity: 50 mg in 1 1
Code: TH25PD4CCB
Classification: ACTIR
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
PARAFFINInactive
Code: I9O0E3H2ZE
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT

Metoprolol Succinate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code70842-110
Application NumberNDA019962
Product Classification
M
Marketing Category
C73594
G
Generic Name
Metoprolol Succinate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 28, 2022
FDA Product Classification

INGREDIENTS (7)

METOPROLOL SUCCINATEActive
Quantity: 25 mg in 1 1
Code: TH25PD4CCB
Classification: ACTIR
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
PARAFFINInactive
Code: I9O0E3H2ZE
Classification: IACT

Metoprolol Succinate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code70842-112
Application NumberNDA019962
Product Classification
M
Marketing Category
C73594
G
Generic Name
Metoprolol Succinate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 28, 2022
FDA Product Classification

INGREDIENTS (7)

METOPROLOL SUCCINATEActive
Quantity: 100 mg in 1 1
Code: TH25PD4CCB
Classification: ACTIR
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
PARAFFINInactive
Code: I9O0E3H2ZE
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT

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TOPROL XL - FDA Drug Approval Details