Metoprolol Succinate
These highlights do not include all the information needed to use metoprolol succinate extended-release tablets safely and effectively. See full prescribing information for metoprolol succinate extended-release tablets. METOPROLOL succinate extended-release tablets USP, for oral useInitial U.S. Approval: 1992
Approved
Approval ID
6cfe96df-bd75-432d-b2c2-e26143ca36dd
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 26, 2022
Manufacturers
FDA
Oryza Pharmaceuticals, Inc
DUNS: 080337493
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 Code72516-031
Application NumberANDA207206
Product Classification
M
Marketing Category
C73584
G
Generic Name
Metoprolol Succinate
Product Specifications
Route of AdministrationORAL
Effective DateApril 27, 2022
FDA Product Classification
INGREDIENTS (10)
METOPROLOL TARTRATEActive
Quantity: 50 mg in 1 1
Code: W5S57Y3A5L
Classification: ACTIB
ETHYLCELLULOSE (10 MPA.S)Inactive
Code: 3DYK7UYZ62
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
HYPROMELLOSE 2208 (4000 MPA.S)Inactive
Code: 39J80LT57T
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
Metoprolol Succinate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72516-033
Application NumberANDA207206
Product Classification
M
Marketing Category
C73584
G
Generic Name
Metoprolol Succinate
Product Specifications
Route of AdministrationORAL
Effective DateApril 27, 2022
FDA Product Classification
INGREDIENTS (10)
METOPROLOL TARTRATEActive
Quantity: 200 mg in 1 1
Code: W5S57Y3A5L
Classification: ACTIB
HYPROMELLOSE 2208 (4000 MPA.S)Inactive
Code: 39J80LT57T
Classification: IACT
ETHYLCELLULOSE (10 MPA.S)Inactive
Code: 3DYK7UYZ62
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
Metoprolol Succinate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72516-032
Application NumberANDA207206
Product Classification
M
Marketing Category
C73584
G
Generic Name
Metoprolol Succinate
Product Specifications
Route of AdministrationORAL
Effective DateApril 27, 2022
FDA Product Classification
INGREDIENTS (10)
METOPROLOL TARTRATEActive
Quantity: 100 mg in 1 1
Code: W5S57Y3A5L
Classification: ACTIB
ETHYLCELLULOSE (10 MPA.S)Inactive
Code: 3DYK7UYZ62
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
HYPROMELLOSE 2208 (4000 MPA.S)Inactive
Code: 39J80LT57T
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95
Classification: IACT
Metoprolol Succinate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72516-030
Application NumberANDA207206
Product Classification
M
Marketing Category
C73584
G
Generic Name
Metoprolol Succinate
Product Specifications
Route of AdministrationORAL
Effective DateApril 27, 2022
FDA Product Classification
INGREDIENTS (10)
HYPROMELLOSE 2208 (4000 MPA.S)Inactive
Code: 39J80LT57T
Classification: IACT
METOPROLOL TARTRATEActive
Quantity: 25 mg in 1 1
Code: W5S57Y3A5L
Classification: ACTIB
ETHYLCELLULOSE (10 MPA.S)Inactive
Code: 3DYK7UYZ62
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT