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TOPROL

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

991fe00b-498b-400e-9e5b-921cb07d9b2c

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Apr 24, 2023

Manufacturers
FDA

Aralez Pharmaceuticals US Inc.

DUNS: 097630187

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 Code70347-200
Application NumberNDA019962
Product Classification
M
Marketing Category
C73594
G
Generic Name
Metoprolol succinate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 30, 2022
FDA Product Classification

INGREDIENTS (7)

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

Metoprolol succinate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code70347-100
Application NumberNDA019962
Product Classification
M
Marketing Category
C73594
G
Generic Name
Metoprolol succinate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 30, 2022
FDA Product Classification

INGREDIENTS (7)

SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
METOPROLOL SUCCINATEActive
Quantity: 100 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
PARAFFINInactive
Code: I9O0E3H2ZE
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT

Metoprolol succinate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code70347-050
Application NumberNDA019962
Product Classification
M
Marketing Category
C73594
G
Generic Name
Metoprolol succinate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 30, 2022
FDA Product Classification

INGREDIENTS (7)

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

Metoprolol succinate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code70347-025
Application NumberNDA019962
Product Classification
M
Marketing Category
C73594
G
Generic Name
Metoprolol succinate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 30, 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
PARAFFINInactive
Code: I9O0E3H2ZE
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT

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TOPROL - FDA Drug Approval Details