Label: TELMISARTAN AND HYDROCHLOROTHIAZIDE tablet

  • NDC Code(s): 70771-1123-2, 70771-1123-3, 70771-1123-8, 70771-1123-9, view more
    70771-1124-2, 70771-1124-3, 70771-1124-8, 70771-1124-9, 70771-1125-2, 70771-1125-3, 70771-1125-8, 70771-1125-9
  • Packager: Zydus Lifesciences Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 17, 2022

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  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 70771-1123-9 in bottle of 90 tablets

    Telmisartan and Hydrochlorthaizide Tablets USP, 40 mg/12.5 mg

    Rx only

    90 tablets

    Telmisartan HCTZ Tablet

    NDC 70771-1124-9 in bottle of 90 tablets

    Telmisartan and Hydrochlorthaizide Tablets USP, 80 mg/12.5 mg

    Rx only

    90 tablets

    Telmisartan HCTZ Tablet

    NDC 70771-1125-9 in bottle of 90 tablets

    Telmisartan and Hydrochlorthaizide Tablets USP, 80 mg/25 mg

    Rx only

    90 tablets

    Telmisartan HCTZ Tablet
  • INGREDIENTS AND APPEARANCE
    TELMISARTAN AND HYDROCHLOROTHIAZIDE 
    telmisartan and hydrochlorothiazide tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1123
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TELMISARTAN (UNII: U5SYW473RQ) (TELMISARTAN - UNII:U5SYW473RQ) TELMISARTAN40 mg
    HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH) HYDROCHLOROTHIAZIDE12.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    MEGLUMINE (UNII: 6HG8UB2MUY)  
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
    SORBITOL (UNII: 506T60A25R)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColorBROWN (Mottled Light brown to Mottled Brown) , WHITE (WHITE TO OFF WHITE) Scoreno score
    ShapeOVAL (Oblong Shaped) Size15mm
    FlavorImprint Code 513
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1123-330 in 1 BOTTLE; Type 0: Not a Combination Product10/12/2017
    2NDC:70771-1123-990 in 1 BOTTLE; Type 0: Not a Combination Product10/12/2017
    3NDC:70771-1123-83 in 1 CARTON10/12/2017
    3NDC:70771-1123-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20422110/12/2017
    TELMISARTAN AND HYDROCHLOROTHIAZIDE 
    telmisartan and hydrochlorothiazide tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1124
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TELMISARTAN (UNII: U5SYW473RQ) (TELMISARTAN - UNII:U5SYW473RQ) TELMISARTAN80 mg
    HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH) HYDROCHLOROTHIAZIDE12.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    MEGLUMINE (UNII: 6HG8UB2MUY)  
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
    SORBITOL (UNII: 506T60A25R)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColorBROWN (Mottled Light brown to Mottled Brown) , WHITE (WHITE TO OFF WHITE) Scoreno score
    ShapeOVAL (Oblong Shaped) Size17mm
    FlavorImprint Code 514
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1124-330 in 1 BOTTLE; Type 0: Not a Combination Product10/12/2017
    2NDC:70771-1124-990 in 1 BOTTLE; Type 0: Not a Combination Product10/12/2017
    3NDC:70771-1124-83 in 1 CARTON10/12/2017
    3NDC:70771-1124-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20422110/12/2017
    TELMISARTAN AND HYDROCHLOROTHIAZIDE 
    telmisartan and hydrochlorothiazide tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1125
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TELMISARTAN (UNII: U5SYW473RQ) (TELMISARTAN - UNII:U5SYW473RQ) TELMISARTAN80 mg
    HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH) HYDROCHLOROTHIAZIDE25 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    MEGLUMINE (UNII: 6HG8UB2MUY)  
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
    SORBITOL (UNII: 506T60A25R)  
    TALC (UNII: 7SEV7J4R1U)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    Product Characteristics
    ColorBROWN (Mottled Light brown to Mottled Brown) , YELLOW (YELLOW) Scoreno score
    ShapeOVAL (Oblong Shaped) Size17mm
    FlavorImprint Code 515
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1125-330 in 1 BOTTLE; Type 0: Not a Combination Product10/12/2017
    2NDC:70771-1125-990 in 1 BOTTLE; Type 0: Not a Combination Product10/12/2017
    3NDC:70771-1125-83 in 1 CARTON10/12/2017
    3NDC:70771-1125-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20422110/12/2017
    Labeler - Zydus Lifesciences Limited (918596198)
    Registrant - Zydus Lifesciences Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zydus Lifesciences Limited918596198ANALYSIS(70771-1123, 70771-1124, 70771-1125) , MANUFACTURE(70771-1123, 70771-1124, 70771-1125)
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