Label: ESCITALOPRAM tablet, film coated

  • NDC Code(s): 70771-1145-0, 70771-1145-1, 70771-1145-3, 70771-1145-5, view more
    70771-1145-9, 70771-1146-0, 70771-1146-1, 70771-1146-3, 70771-1146-5, 70771-1146-9, 70771-1147-0, 70771-1147-1, 70771-1147-3, 70771-1147-5, 70771-1147-9
  • Packager: Zydus Lifesciences Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 5, 2022

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  • SPL MEDGUIDE

    Manufactured by:

    Cadila Healthcare Ltd.

    India.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 70771-1145-9 in bottle of 90 tablets

    Escitalopram Oxalate Tablets USP, 5 mg

    Rx only

    90 tablets

    Escitalopram Oxalate Tablets, 5 mg

    NDC 70771-1146-9 in bottle of 90 tablets

    Escitalopram Oxalate Tablets USP, 10 mg

    Rx only

    90 tablets

    Escitalopram Oxalate Tablets, 10 mg

    NDC 70771-1147-9 in bottle of 90 tablets

    Escitalopram Oxalate Tablets USP, 20 mg

    Rx only

    90 tablets

    Escitalopram Oxalate Tablets, 20 mg
  • INGREDIENTS AND APPEARANCE
    ESCITALOPRAM 
    escitalopram tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1145
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ESCITALOPRAM OXALATE (UNII: 5U85DBW7LO) (ESCITALOPRAM - UNII:4O4S742ANY) ESCITALOPRAM5 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
    ShapeROUND (ROUND) Size6mm
    FlavorImprint Code ZC;37
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1145-330 in 1 BOTTLE; Type 0: Not a Combination Product12/07/2017
    2NDC:70771-1145-1100 in 1 BOTTLE; Type 0: Not a Combination Product12/07/2017
    3NDC:70771-1145-990 in 1 BOTTLE; Type 0: Not a Combination Product12/07/2017
    4NDC:70771-1145-5500 in 1 BOTTLE; Type 0: Not a Combination Product12/07/2017
    5NDC:70771-1145-01000 in 1 BOTTLE; Type 0: Not a Combination Product12/07/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07773412/07/2017
    ESCITALOPRAM 
    escitalopram tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1146
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ESCITALOPRAM OXALATE (UNII: 5U85DBW7LO) (ESCITALOPRAM - UNII:4O4S742ANY) ESCITALOPRAM10 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) Score2 pieces
    ShapeROUND (ROUND) Size8mm
    FlavorImprint Code ZC;23
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1146-330 in 1 BOTTLE; Type 0: Not a Combination Product12/07/2017
    2NDC:70771-1146-990 in 1 BOTTLE; Type 0: Not a Combination Product12/07/2017
    3NDC:70771-1146-1100 in 1 BOTTLE; Type 0: Not a Combination Product12/07/2017
    4NDC:70771-1146-5500 in 1 BOTTLE; Type 0: Not a Combination Product12/07/2017
    5NDC:70771-1146-01000 in 1 BOTTLE; Type 0: Not a Combination Product12/07/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07773412/07/2017
    ESCITALOPRAM 
    escitalopram tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1147
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ESCITALOPRAM OXALATE (UNII: 5U85DBW7LO) (ESCITALOPRAM - UNII:4O4S742ANY) ESCITALOPRAM20 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) Score2 pieces
    ShapeROUND (ROUND) Size10mm
    FlavorImprint Code ZC;24
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1147-330 in 1 BOTTLE; Type 0: Not a Combination Product12/07/2017
    2NDC:70771-1147-990 in 1 BOTTLE; Type 0: Not a Combination Product12/07/2017
    3NDC:70771-1147-1100 in 1 BOTTLE; Type 0: Not a Combination Product12/07/2017
    4NDC:70771-1147-5500 in 1 BOTTLE; Type 0: Not a Combination Product12/07/2017
    5NDC:70771-1147-01000 in 1 BOTTLE; Type 0: Not a Combination Product12/07/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07773412/07/2017
    Labeler - Zydus Lifesciences Limited (918596198)
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