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 September 28, 2023

If you are a consumer or patient please visit this version.

View All Sections
  • SPL UNCLASSIFIED SECTION

  • SPL MEDGUIDE

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 70771-1576-8

    Triazolam Tablets USP, 0.125 mg

    10 Tablets

    Rx only

    0.125 mg label

    NDC 70771-1162- 8

    Triazolam Tablets USP, 0.25 mg

    10 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)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!