Label: VENLAFAXINE HYDROCHLORIDE tablet

  • NDC Code(s): 65841-671-01, 65841-671-05, 65841-671-06, 65841-671-10, view more
    65841-671-14, 65841-671-16, 65841-672-01, 65841-672-05, 65841-672-06, 65841-672-10, 65841-672-14, 65841-672-16, 65841-673-01, 65841-673-05, 65841-673-06, 65841-673-10, 65841-673-14, 65841-673-16, 65841-674-01, 65841-674-05, 65841-674-06, 65841-674-10, 65841-674-14, 65841-674-16, 65841-675-01, 65841-675-05, 65841-675-06, 65841-675-10, 65841-675-14, 65841-675-16
  • Packager: Zydus Lifesciences Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated August 14, 2024

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  • SPL UNCLASSIFIED SECTION

  • SPL MEDGUIDE

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 65841-671-01 in bottle of 100 Tablets

    Venlafaxine Hydrochloride Tablets, 25 mg

    Rx only

    100 TABLETS

     

    Venlafaxine Tablets USP, 25 mg

    NDC 65841-672-01 in bottle of 100 Tablets

    Venlafaxine Hydrochloride Tablets, 37.5 mg

    Rx only

    100 TABLETS

     

    Venlafaxine Tablets USP, 37.5 mg

    NDC 65841-673-01 in bottle of 100 Tablets

    Venlafaxine Hydrochloride Tablets, 50 mg

    Rx only

    100 TABLETS

    Venlafaxine Tablets USP, 50 mg

    NDC 65841-674-01 in bottle of 100 Tablets

    Venlafaxine Hydrochloride Tablets, 75 mg

    Rx only

    100 TABLETS

    Venlafaxine Tablets USP, 75 mg

    NDC 65841-675-01 in bottle of 100 Tablets

    Venlafaxine Hydrochloride Tablets, 100 mg

    Rx only

    100 TABLETS

    Venlafaxine Tablets USP, 100 mg
  • INGREDIENTS AND APPEARANCE
    VENLAFAXINE HYDROCHLORIDE 
    venlafaxine hydrochloride tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-671
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    VENLAFAXINE HYDROCHLORIDE (UNII: 7D7RX5A8MO) (VENLAFAXINE - UNII:GRZ5RCB1QG) VENLAFAXINE25 mg
    Inactive Ingredients
    Ingredient NameStrength
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorORANGE (PEACH) Score2 pieces
    ShapeROUND (ROUND) Size6mm
    FlavorImprint Code ZC;64
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-671-0630 in 1 BOTTLE; Type 0: Not a Combination Product06/13/2008
    2NDC:65841-671-1460 in 1 BOTTLE; Type 0: Not a Combination Product06/13/2008
    3NDC:65841-671-1690 in 1 BOTTLE; Type 0: Not a Combination Product06/13/2008
    4NDC:65841-671-01100 in 1 BOTTLE; Type 0: Not a Combination Product06/13/2008
    5NDC:65841-671-05500 in 1 BOTTLE; Type 0: Not a Combination Product06/13/2008
    6NDC:65841-671-101000 in 1 BOTTLE; Type 0: Not a Combination Product06/13/2008
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07765306/13/2008
    VENLAFAXINE HYDROCHLORIDE 
    venlafaxine hydrochloride tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-672
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    VENLAFAXINE HYDROCHLORIDE (UNII: 7D7RX5A8MO) (VENLAFAXINE - UNII:GRZ5RCB1QG) VENLAFAXINE37.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorORANGE (PEACH) Score2 pieces
    ShapeROUND (ROUND) Size7mm
    FlavorImprint Code ZC;65
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-672-0630 in 1 BOTTLE; Type 0: Not a Combination Product06/13/2008
    2NDC:65841-672-1460 in 1 BOTTLE; Type 0: Not a Combination Product06/13/2008
    3NDC:65841-672-1690 in 1 BOTTLE; Type 0: Not a Combination Product06/13/2008
    4NDC:65841-672-01100 in 1 BOTTLE; Type 0: Not a Combination Product06/13/2008
    5NDC:65841-672-05500 in 1 BOTTLE; Type 0: Not a Combination Product06/13/2008
    6NDC:65841-672-101000 in 1 BOTTLE; Type 0: Not a Combination Product06/13/2008
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07765306/13/2008
    VENLAFAXINE HYDROCHLORIDE 
    venlafaxine hydrochloride tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-673
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    VENLAFAXINE HYDROCHLORIDE (UNII: 7D7RX5A8MO) (VENLAFAXINE - UNII:GRZ5RCB1QG) VENLAFAXINE50 mg
    Inactive Ingredients
    Ingredient NameStrength
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorORANGE (PEACH) Score2 pieces
    ShapeROUND (ROUND) Size8mm
    FlavorImprint Code ZC;66
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-673-0630 in 1 BOTTLE; Type 0: Not a Combination Product06/13/2008
    2NDC:65841-673-1460 in 1 BOTTLE; Type 0: Not a Combination Product06/13/2008
    3NDC:65841-673-1690 in 1 BOTTLE; Type 0: Not a Combination Product06/13/2008
    4NDC:65841-673-01100 in 1 BOTTLE; Type 0: Not a Combination Product06/13/2008
    5NDC:65841-673-05500 in 1 BOTTLE; Type 0: Not a Combination Product06/13/2008
    6NDC:65841-673-101000 in 1 BOTTLE; Type 0: Not a Combination Product06/13/2008
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07765306/13/2008
    VENLAFAXINE HYDROCHLORIDE 
    venlafaxine hydrochloride tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-674
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    VENLAFAXINE HYDROCHLORIDE (UNII: 7D7RX5A8MO) (VENLAFAXINE - UNII:GRZ5RCB1QG) VENLAFAXINE75 mg
    Inactive Ingredients
    Ingredient NameStrength
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorORANGE (PEACH) Score2 pieces
    ShapeROUND (ROUND) Size10mm
    FlavorImprint Code ZC;67
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-674-0630 in 1 BOTTLE; Type 0: Not a Combination Product06/13/2008
    2NDC:65841-674-1460 in 1 BOTTLE; Type 0: Not a Combination Product06/13/2008
    3NDC:65841-674-1690 in 1 BOTTLE; Type 0: Not a Combination Product06/13/2008
    4NDC:65841-674-01100 in 1 BOTTLE; Type 0: Not a Combination Product06/13/2008
    5NDC:65841-674-05500 in 1 BOTTLE; Type 0: Not a Combination Product06/13/2008
    6NDC:65841-674-101000 in 1 BOTTLE; Type 0: Not a Combination Product06/13/2008
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07765306/13/2008
    VENLAFAXINE HYDROCHLORIDE 
    venlafaxine hydrochloride tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-675
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    VENLAFAXINE HYDROCHLORIDE (UNII: 7D7RX5A8MO) (VENLAFAXINE - UNII:GRZ5RCB1QG) VENLAFAXINE100 mg
    Inactive Ingredients
    Ingredient NameStrength
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorORANGE (PEACH) Score2 pieces
    ShapeROUND (ROUND) Size10mm
    FlavorImprint Code ZC;68
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-675-0630 in 1 BOTTLE; Type 0: Not a Combination Product06/13/2008
    2NDC:65841-675-1460 in 1 BOTTLE; Type 0: Not a Combination Product06/13/2008
    3NDC:65841-675-1690 in 1 BOTTLE; Type 0: Not a Combination Product06/13/2008
    4NDC:65841-675-01100 in 1 BOTTLE; Type 0: Not a Combination Product06/13/2008
    5NDC:65841-675-05500 in 1 BOTTLE; Type 0: Not a Combination Product06/13/2008
    6NDC:65841-675-101000 in 1 BOTTLE; Type 0: Not a Combination Product06/13/2008
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07765306/13/2008
    Labeler - Zydus Lifesciences Limited (918596198)
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