metoprolol succinate
Metoprolol Succinate Extended-Release Tablets, USP100 mg and 200 mg
Approved
Approval ID
2d948600-35d8-4490-983b-918bdce488c8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 1, 2009
Manufacturers
FDA
Ethex Corporation
DUNS: 615424686
Products 2
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 Code58177-358
Application NumberANDA076640
Product Classification
M
Marketing Category
C73584
G
Generic Name
metoprolol succinate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 1, 2009
FDA Product Classification
INGREDIENTS (17)
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
metoprolol succinateActive
Quantity: 190 mg in 1 1
Code: TH25PD4CCB
Classification: ACTIB
CARBOXYMETHYLCELLULOSE SODIUMInactive
Code: K679OBS311
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSEInactive
Code: 3NXW29V3WO
Classification: IACT
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)Inactive
Code: 74G4R6TH13
Classification: IACT
GLYCERYL BEHENATEInactive
Code: R8WTH25YS2
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
metoprolol succinate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code58177-368
Application NumberANDA076640
Product Classification
M
Marketing Category
C73584
G
Generic Name
metoprolol succinate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 1, 2009
FDA Product Classification
INGREDIENTS (17)
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
metoprolol succinateActive
Quantity: 90 mg in 1 1
Code: TH25PD4CCB
Classification: ACTIB
CARBOXYMETHYLCELLULOSE SODIUMInactive
Code: K679OBS311
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
GLYCERYL BEHENATEInactive
Code: R8WTH25YS2
Classification: IACT
HYPROMELLOSEInactive
Code: 3NXW29V3WO
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)Inactive
Code: 74G4R6TH13
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT