Label: DESVENLAFAXINE tablet, extended release

  • NDC Code(s): 70771-1311-0, 70771-1311-1, 70771-1311-2, 70771-1311-3, view more
    70771-1311-4, 70771-1311-5, 70771-1311-7, 70771-1311-9, 70771-1312-0, 70771-1312-1, 70771-1312-2, 70771-1312-3, 70771-1312-4, 70771-1312-5, 70771-1312-7, 70771-1312-9
  • Packager: Cadila Healthcare Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated August 18, 2020

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  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 68382-469-67 in bottle of 14 tablets in unit-of-use package

    Desvenlafaxine Extended-release Tablets, 50 mg

    14 tablets

    Rx  only

    Zydus

    Desvenlafaxine tablets

    NDC 68382-741-67 in bottle of 14 tablets in unit-of-use package

    Desvenlafaxine Extended-release Tablets, 100 mg

    14 tablets

    Rx  only

    Zydus

    Desvenlafaxine tablets
  • INGREDIENTS AND APPEARANCE
    DESVENLAFAXINE 
    desvenlafaxine tablet, extended release
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1311
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DESVENLAFAXINE (UNII: NG99554ANW) (DESVENLAFAXINE - UNII:NG99554ANW) DESVENLAFAXINE50 mg
    Inactive Ingredients
    Ingredient NameStrength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
    ShapeSQUARE (SQUARE) Size9mm
    FlavorImprint Code 469
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1311-714 in 1 BOTTLE; Type 0: Not a Combination Product05/08/2018
    2NDC:70771-1311-330 in 1 BOTTLE; Type 0: Not a Combination Product05/08/2018
    3NDC:70771-1311-990 in 1 BOTTLE; Type 0: Not a Combination Product05/08/2018
    4NDC:70771-1311-1100 in 1 BOTTLE; Type 0: Not a Combination Product05/08/2018
    5NDC:70771-1311-5500 in 1 BOTTLE; Type 0: Not a Combination Product05/08/2018
    6NDC:70771-1311-01000 in 1 BOTTLE; Type 0: Not a Combination Product05/08/2018
    7NDC:70771-1311-410 in 1 CARTON05/08/2018
    7NDC:70771-1311-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20402005/08/2018
    DESVENLAFAXINE 
    desvenlafaxine tablet, extended release
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1312
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DESVENLAFAXINE (UNII: NG99554ANW) (DESVENLAFAXINE - UNII:NG99554ANW) DESVENLAFAXINE100 mg
    Inactive Ingredients
    Ingredient NameStrength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorORANGE (ORANGE) Scoreno score
    ShapeSQUARE (SQUARE) Size9mm
    FlavorImprint Code 741
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1312-714 in 1 BOTTLE; Type 0: Not a Combination Product05/08/2018
    2NDC:70771-1312-330 in 1 BOTTLE; Type 0: Not a Combination Product05/08/2018
    3NDC:70771-1312-990 in 1 BOTTLE; Type 0: Not a Combination Product05/08/2018
    4NDC:70771-1312-1100 in 1 BOTTLE; Type 0: Not a Combination Product05/08/2018
    5NDC:70771-1312-5500 in 1 BOTTLE; Type 0: Not a Combination Product05/08/2018
    6NDC:70771-1312-01000 in 1 BOTTLE; Type 0: Not a Combination Product05/08/2018
    7NDC:70771-1312-410 in 1 CARTON05/08/2018
    7NDC:70771-1312-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20402005/08/2018
    Labeler - Cadila Healthcare Limited (918596198)
    Registrant - Cadila Healthcare Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited918596198ANALYSIS(70771-1311, 70771-1312) , MANUFACTURE(70771-1311, 70771-1312)
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