Metoprolol Tartrate
METOPROLOL TARTRATE - metoprolol tartrate tablet, film coatedRubicon Research Private Limited
Approved
Approval ID
50efcc03-559c-4d53-89ff-f2dc35384241
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 27, 2014
Manufacturers
FDA
Rubicon Research Private Limited
DUNS: 918629544
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 Code49930-003
Application NumberANDA200981
Product Classification
M
Marketing Category
C73584
G
Generic Name
Metoprolol Tartrate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 11, 2014
FDA Product Classification
INGREDIENTS (11)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
METOPROLOL TARTRATEActive
Quantity: 100 mg in 1 1
Code: W5S57Y3A5L
Classification: ACTIB
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
D&C RED NO. 30Inactive
Code: 2S42T2808B
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
Metoprolol Tartrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49930-002
Application NumberANDA200981
Product Classification
M
Marketing Category
C73584
G
Generic Name
Metoprolol Tartrate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 11, 2014
FDA Product Classification
INGREDIENTS (11)
METOPROLOL TARTRATEActive
Quantity: 50 mg in 1 1
Code: W5S57Y3A5L
Classification: ACTIB
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
D&C RED NO. 30Inactive
Code: 2S42T2808B
Classification: IACT
Metoprolol Tartrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49930-001
Application NumberANDA200981
Product Classification
M
Marketing Category
C73584
G
Generic Name
Metoprolol Tartrate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 11, 2014
FDA Product Classification
INGREDIENTS (10)
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
D&C RED NO. 30Inactive
Code: 2S42T2808B
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
METOPROLOL TARTRATEActive
Quantity: 25 mg in 1 1
Code: W5S57Y3A5L
Classification: ACTIB