Label: ROFLUMILAST tablet

  • NDC Code(s): 70771-1673-2, 70771-1673-3, 70771-1673-8, 70771-1674-3, view more
    70771-1674-9
  • Packager: Zydus Lifesciences Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated September 27, 2023

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  • SPL UNCLASSIFIED SECTION

  • SPL MEDGUIDE

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 70771-1674-3

    Roflumilast Tablets, 500 mcg

    30 tablets

    Rx only

    500 mcg label

    NDC 70771-1673-8

    Roflumilast Tablets, 250 mcg

    Blister pack of 28 tablets

    Rx only

    250 mcg blister label
  • INGREDIENTS AND APPEARANCE
    ROFLUMILAST 
    roflumilast tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1674
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ROFLUMILAST (UNII: 0P6C6ZOP5U) (ROFLUMILAST - UNII:0P6C6ZOP5U) ROFLUMILAST500 ug
    Inactive Ingredients
    Ingredient NameStrength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorWHITE (off-white) Scoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code T5
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1674-330 in 1 BOTTLE; Type 0: Not a Combination Product10/03/2022
    2NDC:70771-1674-990 in 1 BOTTLE; Type 0: Not a Combination Product10/03/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20830310/03/2022
    ROFLUMILAST 
    roflumilast tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1673
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ROFLUMILAST (UNII: 0P6C6ZOP5U) (ROFLUMILAST - UNII:0P6C6ZOP5U) ROFLUMILAST250 ug
    Inactive Ingredients
    Ingredient NameStrength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorWHITE (off-white) Scoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code T6
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1673-81 in 1 CARTON05/18/2023
    128 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:70771-1673-32 in 1 CARTON05/18/2023
    2NDC:70771-1673-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20830305/18/2023
    Labeler - Zydus Lifesciences Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zydus Lifesciences Limited863362789ANALYSIS(70771-1673, 70771-1674) , MANUFACTURE(70771-1673, 70771-1674)
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