Label: TRIAZOLAM tablet

  • NDC Code(s): 70771-1162-1, 70771-1162-5, 70771-1162-8, 70771-1576-1, view more
    70771-1576-5, 70771-1576-8
  • Packager: Zydus Lifesciences Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: CIV
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated August 14, 2024

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  • SPL UNCLASSIFIED SECTION

  • SPL MEDGUIDE

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 70771-1576-1

    Triazolam Tablets USP, 0.125 mg

    100 Tablets

    Rx only

    0.125 mg label

    NDC 70771-1162- 1

    Triazolam Tablets USP, 0.25 mg

    100 Tablets

    Rx only

    0.25 mg label
  • INGREDIENTS AND APPEARANCE
    TRIAZOLAM 
    triazolam tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1162
    Route of AdministrationORALDEA ScheduleCIV    
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRIAZOLAM (UNII: 1HM943223R) (TRIAZOLAM - UNII:1HM943223R) TRIAZOLAM0.25 mg
    Inactive Ingredients
    Ingredient NameStrength
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POVIDONE (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorGRAY (light-grayish blue) Score2 pieces
    ShapeOVAL (elliptical) Size8mm
    FlavorImprint Code 12;89
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1162-810 in 1 BOTTLE; Type 0: Not a Combination Product12/30/2022
    2NDC:70771-1162-5500 in 1 BOTTLE; Type 0: Not a Combination Product12/30/2022
    3NDC:70771-1162-1100 in 1 BOTTLE; Type 0: Not a Combination Product12/30/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21300312/30/2022
    TRIAZOLAM 
    triazolam tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1576
    Route of AdministrationORALDEA ScheduleCIV    
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRIAZOLAM (UNII: 1HM943223R) (TRIAZOLAM - UNII:1HM943223R) TRIAZOLAM0.125 mg
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POVIDONE (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorWHITE (off-white) Scoreno score
    ShapeOVAL (elliptical) Size8mm
    FlavorImprint Code 1521
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1576-810 in 1 BOTTLE; Type 0: Not a Combination Product12/30/2022
    2NDC:70771-1576-5500 in 1 BOTTLE; Type 0: Not a Combination Product12/30/2022
    3NDC:70771-1576-1100 in 1 BOTTLE; Type 0: Not a Combination Product12/30/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21300312/30/2022
    Labeler - Zydus Lifesciences Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zydus Lifesciences Limited918596198ANALYSIS(70771-1576, 70771-1162) , MANUFACTURE(70771-1576, 70771-1162)
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