Label: DEXAMETHASONE tablet

  • NDC Code(s): 70771-1699-1, 70771-1700-1, 70771-1704-1, 70771-1705-1, view more
    70771-1707-1
  • Packager: Zydus Lifesciences Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated March 30, 2024

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

  • SPL UNCLASSIFIED

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 70771-1704-1

    Dexamethasone Tablets, USP 0.5 mg

    100 Tablets

    Rx only

    Zydus

    Dexamethasone tablets 0.5 mg

    NDC 70771-1705-1

    Dexamethasone Tablets, USP 0.75 mg

    100 Tablets

    Rx only

    Zydus

    Dexamethasone tablets 0.75 mg

    NDC 70771-1707-1

    Dexamethasone Tablets, USP 1.5 mg

    100 Tablets

    Rx only

    Zydus

    Dexamethasone tablets 1.5 mg

    NDC 70771-1699-1

    Dexamethasone Tablets, USP 4 mg

    100 Tablets

    Rx only

    Zydus

    Dexamethasone tablets 4 mg

    NDC 70771-1700-1

    Dexamethasone Tablets, USP 6 mg

    100 Tablets

    Rx only

    Zydus

    Dexamethasone tablets 6 mg
  • INGREDIENTS AND APPEARANCE
    DEXAMETHASONE 
    dexamethasone tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1699
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXAMETHASONE (UNII: 7S5I7G3JQL) (DEXAMETHASONE - UNII:7S5I7G3JQL) DEXAMETHASONE4 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorGREEN (off-white to light green) Score2 pieces
    ShapeROUNDSize6mm
    FlavorImprint Code 1736
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1699-1100 in 1 BOTTLE; Type 0: Not a Combination Product04/15/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21628204/15/2024
    DEXAMETHASONE 
    dexamethasone tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1700
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXAMETHASONE (UNII: 7S5I7G3JQL) (DEXAMETHASONE - UNII:7S5I7G3JQL) DEXAMETHASONE6 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorBLUE (off-white to light blue) Score2 pieces
    ShapeROUNDSize6mm
    FlavorImprint Code 1737
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1700-1100 in 1 BOTTLE; Type 0: Not a Combination Product04/15/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21628204/15/2024
    DEXAMETHASONE 
    dexamethasone tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1704
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXAMETHASONE (UNII: 7S5I7G3JQL) (DEXAMETHASONE - UNII:7S5I7G3JQL) DEXAMETHASONE0.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorYELLOW (light yellow to yellow) Score2 pieces
    ShapeOVALSize6mm
    FlavorImprint Code 1791
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1704-1100 in 1 BOTTLE; Type 0: Not a Combination Product04/15/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21628204/15/2024
    DEXAMETHASONE 
    dexamethasone tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1705
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXAMETHASONE (UNII: 7S5I7G3JQL) (DEXAMETHASONE - UNII:7S5I7G3JQL) DEXAMETHASONE0.75 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorGRAY (off-white to grey) Score2 pieces
    ShapeOVALSize7mm
    FlavorImprint Code 1792
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1705-1100 in 1 BOTTLE; Type 0: Not a Combination Product04/15/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21628204/15/2024
    DEXAMETHASONE 
    dexamethasone tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1707
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXAMETHASONE (UNII: 7S5I7G3JQL) (DEXAMETHASONE - UNII:7S5I7G3JQL) DEXAMETHASONE1.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorPINK (light-pink to pink) Score2 pieces
    ShapeROUNDSize6mm
    FlavorImprint Code 1795
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1707-1100 in 1 BOTTLE; Type 0: Not a Combination Product04/15/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21628204/15/2024
    Labeler - Zydus Lifesciences Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zydus Lifesciences Limited677605858ANALYSIS(70771-1704, 70771-1705, 70771-1707, 70771-1699, 70771-1700) , MANUFACTURE(70771-1704, 70771-1705, 70771-1707, 70771-1699, 70771-1700)