Lopressor
These highlights do not include all the information needed to use LOPRESSOR safely and effectively. See full prescribing information for LOPRESSOR . LOPRESSOR (metoprolol tart r ate ) t ablet s , for o ral u se Initial U.S. Approval: 1992
Approved
Approval ID
0283bc9d-6998-493a-824a-d4c85f704111
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 14, 2023
Manufacturers
FDA
Validus Pharmaceuticals LLC
DUNS: 801194619
Products 2
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 Code30698-459
Application NumberNDA017963
Product Classification
M
Marketing Category
C73594
G
Generic Name
metoprolol tartrate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 30, 2024
FDA Product Classification
INGREDIENTS (12)
METOPROLOL TARTRATEActive
Quantity: 100 mg in 1 1
Code: W5S57Y3A5L
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
metoprolol tartrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code30698-458
Application NumberNDA017963
Product Classification
M
Marketing Category
C73594
G
Generic Name
metoprolol tartrate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 30, 2024
FDA Product Classification
INGREDIENTS (12)
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
METOPROLOL TARTRATEActive
Quantity: 50 mg in 1 1
Code: W5S57Y3A5L
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
D&C RED NO. 30Inactive
Code: 2S42T2808B
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT