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 Use INITIAL U.S. APPROVAL: 1992
Approved
Approval ID
acad5e19-27c5-44fb-80f7-c05aa6859ecf
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 10, 2013
Manufacturers
FDA
Wockhardt Limited
DUNS: 650069115
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 Code55648-737
Application NumberANDA090615
Product Classification
M
Marketing Category
C73584
G
Generic Name
Metoprolol Succinate
Product Specifications
Route of AdministrationORAL
Effective DateAugust 1, 2013
FDA Product Classification
INGREDIENTS (13)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
METOPROLOL SUCCINATEActive
Quantity: 200 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
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8J
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT