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
8260fd0b-bfec-4113-9eca-4a12b1da0da0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 22, 2023
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
Products 1
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 Code50090-6484
Application NumberANDA203894
Product Classification
M
Marketing Category
C73584
G
Generic Name
metoprolol succinate
Product Specifications
Route of AdministrationORAL
Effective DateApril 5, 2023
FDA Product Classification
INGREDIENTS (13)
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
METOPROLOL SUCCINATEActive
Quantity: 100 mg in 1 1
Code: TH25PD4CCB
Classification: ACTIR
ETHYLCELLULOSE (10 MPA.S)Inactive
Code: 3DYK7UYZ62
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
METHYLCELLULOSE (15 MPA.S)Inactive
Code: NPU9M2E6L8
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT