Label: TELMISARTAN tablet

  • NDC Code(s): 65841-804-01, 65841-804-05, 65841-804-06, 65841-804-10, view more
    65841-804-16, 65841-804-30, 65841-804-78, 65841-805-01, 65841-805-05, 65841-805-06, 65841-805-10, 65841-805-16, 65841-805-30, 65841-805-78, 65841-806-01, 65841-806-05, 65841-806-06, 65841-806-10, 65841-806-16, 65841-806-30, 65841-806-78
  • 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.

  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 65841-804-05 in bottle of 500 tablets

    Telmisartan Tablets USP, 20 mg

    Rx only

    500 tablets

    Telmisartan tablets, 20 mg

    NDC 65841-805-05 in bottle of 500 tablets

    Telmisartan Tablets USP, 40 mg

    Rx only

    500 tablets

    Telmisartan Tablets, 40 mg

    NDC 65841-806-05 in bottle of 500 tablets

    Telmisartan Tablets USP, 80 mg

    Rx only

    500 tablets

    Telmisartan Tablets, 80 mg
  • INGREDIENTS AND APPEARANCE
    TELMISARTAN 
    telmisartan tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-804
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TELMISARTAN (UNII: U5SYW473RQ) (TELMISARTAN - UNII:U5SYW473RQ) TELMISARTAN20 mg
    Inactive Ingredients
    Ingredient NameStrength
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MEGLUMINE (UNII: 6HG8UB2MUY)  
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorBROWN (MOTTLED LIGHT BROWN TO MOTTLED BROWN) Scoreno score
    ShapeROUND (ROUND) Size7mm
    FlavorImprint Code 471
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-804-0630 in 1 BOTTLE; Type 0: Not a Combination Product08/27/2014
    2NDC:65841-804-1690 in 1 BOTTLE; Type 0: Not a Combination Product08/27/2014
    3NDC:65841-804-01100 in 1 BOTTLE; Type 0: Not a Combination Product08/27/2014
    4NDC:65841-804-05500 in 1 BOTTLE; Type 0: Not a Combination Product08/27/2014
    5NDC:65841-804-101000 in 1 BOTTLE; Type 0: Not a Combination Product08/27/2014
    6NDC:65841-804-7830 in 1 CARTON08/27/2014
    6NDC:65841-804-301 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20332508/27/2014
    TELMISARTAN 
    telmisartan tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-805
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TELMISARTAN (UNII: U5SYW473RQ) (TELMISARTAN - UNII:U5SYW473RQ) TELMISARTAN40 mg
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    MEGLUMINE (UNII: 6HG8UB2MUY)  
    POVIDONE (UNII: FZ989GH94E)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    SORBITOL (UNII: 506T60A25R)  
    SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    ColorBROWN (MOTTLED LIGHT BROWN TO MOTTLED BROWN) Scoreno score
    ShapeOVAL (OBLONG) Size12mm
    FlavorImprint Code 472
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-805-0630 in 1 BOTTLE; Type 0: Not a Combination Product08/27/2014
    2NDC:65841-805-1690 in 1 BOTTLE; Type 0: Not a Combination Product08/27/2014
    3NDC:65841-805-01100 in 1 BOTTLE; Type 0: Not a Combination Product08/27/2014
    4NDC:65841-805-05500 in 1 BOTTLE; Type 0: Not a Combination Product08/27/2014
    5NDC:65841-805-101000 in 1 BOTTLE; Type 0: Not a Combination Product08/27/2014
    6NDC:65841-805-7830 in 1 CARTON08/27/2014
    6NDC:65841-805-301 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20332508/27/2014
    TELMISARTAN 
    telmisartan tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-806
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TELMISARTAN (UNII: U5SYW473RQ) (TELMISARTAN - UNII:U5SYW473RQ) TELMISARTAN80 mg
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    MEGLUMINE (UNII: 6HG8UB2MUY)  
    POVIDONE (UNII: FZ989GH94E)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    SORBITOL (UNII: 506T60A25R)  
    SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    ColorBROWN (MOTTLED LIGHT BROWN TO MOTTLED BROWN) Scoreno score
    ShapeOVAL (OBLONG) Size18mm
    FlavorImprint Code 473
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-806-0630 in 1 BOTTLE; Type 0: Not a Combination Product08/27/2014
    2NDC:65841-806-1690 in 1 BOTTLE; Type 0: Not a Combination Product08/27/2014
    3NDC:65841-806-01100 in 1 BOTTLE; Type 0: Not a Combination Product08/27/2014
    4NDC:65841-806-05500 in 1 BOTTLE; Type 0: Not a Combination Product08/27/2014
    5NDC:65841-806-101000 in 1 BOTTLE; Type 0: Not a Combination Product08/27/2014
    6NDC:65841-806-7830 in 1 CARTON08/27/2014
    6NDC:65841-806-301 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20332508/27/2014
    Labeler - Cadila Healthcare Limited (918596198)
    Registrant - Cadila Healthcare Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited918596198ANALYSIS(65841-804, 65841-805, 65841-806) , MANUFACTURE(65841-804, 65841-805, 65841-806)