Metoprolol Tartrate
Approved
Approval ID
3859effa-7b9b-41cd-9c90-847fa99e9b34
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 3, 2014
Manufacturers
FDA
Aphena Pharma Solutions - Tennessee, LLC
DUNS: 128385585
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
metoprolol tartrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67544-627
Application NumberANDA076704
Product Classification
M
Marketing Category
C73584
G
Generic Name
metoprolol tartrate
Product Specifications
Route of AdministrationORAL
Effective DateApril 3, 2014
FDA Product Classification
INGREDIENTS (14)
METOPROLOL TARTRATEActive
Quantity: 100 mg in 1 1
Code: W5S57Y3A5L
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONESInactive
Code: FZ989GH94E
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
metoprolol tartrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67544-911
Application NumberANDA076704
Product Classification
M
Marketing Category
C73584
G
Generic Name
metoprolol tartrate
Product Specifications
Route of AdministrationORAL
Effective DateApril 3, 2014
FDA Product Classification
INGREDIENTS (16)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
POVIDONESInactive
Code: FZ989GH94E
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
D&C RED NO. 27Inactive
Code: 2LRS185U6K
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
METOPROLOL TARTRATEActive
Quantity: 50 mg in 1 1
Code: W5S57Y3A5L
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
metoprolol tartrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67544-567
Application NumberANDA076704
Product Classification
M
Marketing Category
C73584
G
Generic Name
metoprolol tartrate
Product Specifications
Route of AdministrationORAL
Effective DateApril 3, 2014
FDA Product Classification
INGREDIENTS (13)
METOPROLOL TARTRATEActive
Quantity: 25 mg in 1 1
Code: W5S57Y3A5L
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONESInactive
Code: FZ989GH94E
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT