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, for oral useInitial U.S. Approval: 1992
Approved
Approval ID
c20170ea-0e24-4e82-b9cb-aebdbfcc022a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 26, 2019
Manufacturers
FDA
Wockhardt USA LLC.
DUNS: 170508365
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 Code64679-736
Application NumberANDA090615
Product Classification
M
Marketing Category
C73584
G
Generic Name
Metoprolol Succinate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 26, 2019
FDA Product Classification
INGREDIENTS (13)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
METOPROLOL SUCCINATEActive
Quantity: 100 mg in 1 1
Code: TH25PD4CCB
Classification: ACTIR
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
ETHYLCELLULOSESInactive
Code: 7Z8S9VYZ4B
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8J
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Metoprolol Succinate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64679-737
Application NumberANDA090615
Product Classification
M
Marketing Category
C73584
G
Generic Name
Metoprolol Succinate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 26, 2019
FDA Product Classification
INGREDIENTS (13)
METOPROLOL SUCCINATEActive
Quantity: 200 mg in 1 1
Code: TH25PD4CCB
Classification: ACTIR
ETHYLCELLULOSESInactive
Code: 7Z8S9VYZ4B
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Metoprolol Succinate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64679-735
Application NumberANDA090615
Product Classification
M
Marketing Category
C73584
G
Generic Name
Metoprolol Succinate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 26, 2019
FDA Product Classification
INGREDIENTS (13)
ETHYLCELLULOSESInactive
Code: 7Z8S9VYZ4B
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
METOPROLOL SUCCINATEActive
Quantity: 50 mg in 1 1
Code: TH25PD4CCB
Classification: ACTIR
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8J
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
Metoprolol Succinate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64679-734
Application NumberANDA090615
Product Classification
M
Marketing Category
C73584
G
Generic Name
Metoprolol Succinate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 26, 2019
FDA Product Classification
INGREDIENTS (13)
METOPROLOL SUCCINATEActive
Quantity: 25 mg in 1 1
Code: TH25PD4CCB
Classification: ACTIR
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
ETHYLCELLULOSESInactive
Code: 7Z8S9VYZ4B
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8J
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT