Label: SERTRALINE HYDROCHLORIDE tablet, film coated

  • NDC Code(s): 65841-043-01, 65841-043-05, 65841-043-06, 65841-043-10, view more
    65841-043-14, 65841-043-16, 65841-043-18, 65841-044-01, 65841-044-05, 65841-044-06, 65841-044-10, 65841-044-14, 65841-044-16, 65841-045-01, 65841-045-06, 65841-045-14, 65841-045-16, 65841-045-40
  • Packager: Cadila Healthcare Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL

Drug Label Information

Updated September 14, 2020

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • MEDICATION GUIDE

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 65841-043-06 in bottles of 30 tablets

    Sertraline Hydrochloride Tablets, 25 mg

    30 Tablets

    sertraline tablets 25 mg

    NDC 65841-044-06 in bottles of 30 tablets

    Sertraline Hydrochloride Tablets, 50 mg

    30 Tablets

    sertraline tablets 50 mg

    NDC 65841-045-06 in bottles of 30 tablets

    Sertraline Hydrochloride Tablets, 100 mg

    30 Tablets

    sertraline tablets 100 mg
  • INGREDIENTS AND APPEARANCE
    SERTRALINE HYDROCHLORIDE 
    sertraline hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-043
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SERTRALINE HYDROCHLORIDE (UNII: UTI8907Y6X) (SERTRALINE - UNII:QUC7NX6WMB) SERTRALINE25 mg
    Inactive Ingredients
    Ingredient NameStrength
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POVIDONE (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    ColorGREEN (LIGHT GREEN) Score2 pieces
    ShapeROUND (ROUND) Size6mm
    FlavorImprint Code Z;82
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-043-0630 in 1 BOTTLE; Type 0: Not a Combination Product12/02/2017
    2NDC:65841-043-1850 in 1 BOTTLE; Type 0: Not a Combination Product12/02/2017
    3NDC:65841-043-1460 in 1 BOTTLE; Type 0: Not a Combination Product12/02/2017
    4NDC:65841-043-1690 in 1 BOTTLE; Type 0: Not a Combination Product12/02/2017
    5NDC:65841-043-01100 in 1 BOTTLE; Type 0: Not a Combination Product12/02/2017
    6NDC:65841-043-05500 in 1 BOTTLE; Type 0: Not a Combination Product12/02/2017
    7NDC:65841-043-101000 in 1 BOTTLE; Type 0: Not a Combination Product12/02/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07710612/02/2017
    SERTRALINE HYDROCHLORIDE 
    sertraline hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-044
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SERTRALINE HYDROCHLORIDE (UNII: UTI8907Y6X) (SERTRALINE - UNII:QUC7NX6WMB) SERTRALINE50 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POVIDONE (UNII: FZ989GH94E)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    ColorBLUE (LIGHT BLUE) Score2 pieces
    ShapeROUND (ROUND) Size8mm
    FlavorImprint Code Z;81
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-044-0630 in 1 BOTTLE; Type 0: Not a Combination Product12/02/2017
    2NDC:65841-044-1460 in 1 BOTTLE; Type 0: Not a Combination Product12/02/2017
    3NDC:65841-044-1690 in 1 BOTTLE; Type 0: Not a Combination Product12/02/2017
    4NDC:65841-044-01100 in 1 BOTTLE; Type 0: Not a Combination Product12/02/2017
    5NDC:65841-044-05500 in 1 BOTTLE; Type 0: Not a Combination Product12/02/2017
    6NDC:65841-044-101000 in 1 BOTTLE; Type 0: Not a Combination Product12/02/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07710612/02/2017
    SERTRALINE HYDROCHLORIDE 
    sertraline hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-045
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SERTRALINE HYDROCHLORIDE (UNII: UTI8907Y6X) (SERTRALINE - UNII:QUC7NX6WMB) SERTRALINE100 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POVIDONE (UNII: FZ989GH94E)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    ColorYELLOW (YELLOW) Score2 pieces
    ShapeROUND (ROUND) Size10mm
    FlavorImprint Code Z;80
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-045-0630 in 1 BOTTLE; Type 0: Not a Combination Product12/02/2017
    2NDC:65841-045-1460 in 1 BOTTLE; Type 0: Not a Combination Product12/02/2017
    3NDC:65841-045-1690 in 1 BOTTLE; Type 0: Not a Combination Product12/02/2017
    4NDC:65841-045-01100 in 1 BOTTLE; Type 0: Not a Combination Product12/02/2017
    5NDC:65841-045-405000 in 1 BOTTLE; Type 0: Not a Combination Product12/02/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07710612/02/2017
    Labeler - Cadila Healthcare Limited (918596198)
    Registrant - Cadila Healthcare Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited918596198ANALYSIS(65841-043, 65841-044, 65841-045) , MANUFACTURE(65841-043, 65841-044, 65841-045)