Metoprolol Tartrate
METOPROLOL TARTRATE - metoprolol tartrate tablet, film coated Vensun Pharmaceuticals, Inc. R only
Approved
Approval ID
1daa1441-c71d-064f-e054-00144ff8d46c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 3, 2018
Manufacturers
FDA
Vensun Pharmaceuticals, Inc.
DUNS: 078310501
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 Code42543-002
Application NumberANDA200981
Product Classification
M
Marketing Category
C73584
G
Generic Name
Metoprolol Tartrate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 1, 2017
FDA Product Classification
INGREDIENTS (11)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
METOPROLOL TARTRATEActive
Quantity: 50 mg in 1 1
Code: W5S57Y3A5L
Classification: ACTIB
D&C RED NO. 30Inactive
Code: 2S42T2808B
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
Metoprolol Tartrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42543-003
Application NumberANDA200981
Product Classification
M
Marketing Category
C73584
G
Generic Name
Metoprolol Tartrate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 1, 2017
FDA Product Classification
INGREDIENTS (11)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
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: 100 mg in 1 1
Code: W5S57Y3A5L
Classification: ACTIB
Metoprolol Tartrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42543-001
Application NumberANDA200981
Product Classification
M
Marketing Category
C73584
G
Generic Name
Metoprolol Tartrate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 1, 2017
FDA Product Classification
INGREDIENTS (10)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
D&C RED NO. 30Inactive
Code: 2S42T2808B
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
METOPROLOL TARTRATEActive
Quantity: 25 mg in 1 1
Code: W5S57Y3A5L
Classification: ACTIB