Label: VENLAFAXINE HYDROCHLORIDE capsule, extended release

  • NDC Code(s): 65841-751-01, 65841-751-05, 65841-751-06, 65841-751-10, view more
    65841-751-16, 65841-752-01, 65841-752-05, 65841-752-06, 65841-752-10, 65841-752-16, 65841-753-01, 65841-753-05, 65841-753-06, 65841-753-10, 65841-753-16
  • Packager: Cadila Healthcare Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated September 14, 2020

If you are a consumer or patient please visit this version.

  • MEDICATION GUIDE

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 65841-751-10

    Venlafaxine Hydrochloride Extended-release Capsules USP, 37.5 mg

    1000 Capsules

    Rx only

    Venlafaxine hydrochloride extended-release capsules, USP

    NDC 65841-752-10

    Venlafaxine Hydrochloride Extended-release Capsules USP, 75 mg

    1000 Capsules

    Rx only

    Venlafaxine hydrochloride extended-release capsules, USP

    NDC 65841-753-10

    Venlafaxine Hydrochloride Extended-release Capsules USP, 150 mg

    1000 Capsules

    Rx only

    Venlafaxine hydrochloride extended-release capsules, USP
  • INGREDIENTS AND APPEARANCE
    VENLAFAXINE HYDROCHLORIDE 
    venlafaxine hydrochloride capsule, extended release
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-751
    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
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    GELATIN (UNII: 2G86QN327L)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW) (UNII: P2OM2Q86BI)  
    Product Characteristics
    ColorGRAY (GRAY) , WHITE (WHITE) Scoreno score
    ShapeCAPSULE (CAPSULE) Size16mm
    FlavorImprint Code ZA;35;37;5;mg
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-751-0630 in 1 BOTTLE; Type 0: Not a Combination Product06/01/2011
    2NDC:65841-751-1690 in 1 BOTTLE; Type 0: Not a Combination Product06/01/2011
    3NDC:65841-751-01100 in 1 BOTTLE; Type 0: Not a Combination Product06/01/2011
    4NDC:65841-751-05500 in 1 BOTTLE; Type 0: Not a Combination Product06/01/2011
    5NDC:65841-751-101000 in 1 BOTTLE; Type 0: Not a Combination Product06/01/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09017406/01/2011
    VENLAFAXINE HYDROCHLORIDE 
    venlafaxine hydrochloride capsule, extended release
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-752
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    VENLAFAXINE HYDROCHLORIDE (UNII: 7D7RX5A8MO) (VENLAFAXINE - UNII:GRZ5RCB1QG) VENLAFAXINE75 mg
    Inactive Ingredients
    Ingredient NameStrength
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    GELATIN (UNII: 2G86QN327L)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW) (UNII: P2OM2Q86BI)  
    Product Characteristics
    ColorORANGE (PEACH) , WHITE (WHITE) Scoreno score
    ShapeCAPSULE (CAPSULE) Size20mm
    FlavorImprint Code ZA;36;75;mg
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-752-0630 in 1 BOTTLE; Type 0: Not a Combination Product06/01/2011
    2NDC:65841-752-1690 in 1 BOTTLE; Type 0: Not a Combination Product06/01/2011
    3NDC:65841-752-01100 in 1 BOTTLE; Type 0: Not a Combination Product06/01/2011
    4NDC:65841-752-05500 in 1 BOTTLE; Type 0: Not a Combination Product06/01/2011
    5NDC:65841-752-101000 in 1 BOTTLE; Type 0: Not a Combination Product06/01/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09017406/01/2011
    VENLAFAXINE HYDROCHLORIDE 
    venlafaxine hydrochloride capsule, extended release
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-753
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    VENLAFAXINE HYDROCHLORIDE (UNII: 7D7RX5A8MO) (VENLAFAXINE - UNII:GRZ5RCB1QG) VENLAFAXINE150 mg
    Inactive Ingredients
    Ingredient NameStrength
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    GELATIN (UNII: 2G86QN327L)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW) (UNII: P2OM2Q86BI)  
    Product Characteristics
    ColorORANGE (DARK ORANGE) , WHITE (WHITE) Scoreno score
    ShapeCAPSULE (CAPSULE) Size21mm
    FlavorImprint Code ZA;37;150;mg
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-753-0630 in 1 BOTTLE; Type 0: Not a Combination Product06/01/2011
    2NDC:65841-753-1690 in 1 BOTTLE; Type 0: Not a Combination Product06/01/2011
    3NDC:65841-753-01100 in 1 BOTTLE; Type 0: Not a Combination Product06/01/2011
    4NDC:65841-753-05500 in 1 BOTTLE; Type 0: Not a Combination Product06/01/2011
    5NDC:65841-753-101000 in 1 BOTTLE; Type 0: Not a Combination Product06/01/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09017406/01/2011
    Labeler - Cadila Healthcare Limited (918596198)
    Registrant - Cadila Healthcare Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited918596198ANALYSIS(65841-751, 65841-752, 65841-753) , MANUFACTURE(65841-751, 65841-752, 65841-753)