Label: LENALIDOMIDE capsule

  • NDC Code(s): 70771-1677-1, 70771-1677-7, 70771-1678-1, 70771-1678-7, view more
    70771-1679-1, 70771-1679-8, 70771-1681-1, 70771-1681-8
  • Packager: Zydus Lifesciences Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated September 9, 2022

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

  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 70771-1677-7

    Lenalidomide Capsules, 5 mg

    28 Capsules

    Rx only

    5 mg label

    NDC 70771-1678-7

    Lenalidomide Capsules, 10 mg

    28 Capsules

    Rx only

    10 mg label

    NDC 70771-1679-8

    Lenalidomide Capsules, 15 mg

    21 Capsules

    Rx only

    15 mg label

    NDC 70771-1681-8

    Lenalidomide Capsules, 25 mg

    21 Capsules

    Rx only

    25 mg label
  • INGREDIENTS AND APPEARANCE
    LENALIDOMIDE 
    lenalidomide capsule
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1677
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LENALIDOMIDE (UNII: F0P408N6V4) (LENALIDOMIDE - UNII:F0P408N6V4) LENALIDOMIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    GELATIN (UNII: 2G86QN327L)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    SHELLAC (UNII: 46N107B71O)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITE (white opaque cap with white opaque body) Scoreno score
    ShapeCAPSULE (capsule) Size11mm
    FlavorImprint Code 1031
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1677-728 in 1 BOTTLE; Type 0: Not a Combination Product09/12/2022
    2NDC:70771-1677-1100 in 1 BOTTLE; Type 0: Not a Combination Product09/12/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21015409/12/2022
    LENALIDOMIDE 
    lenalidomide capsule
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1678
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LENALIDOMIDE (UNII: F0P408N6V4) (LENALIDOMIDE - UNII:F0P408N6V4) LENALIDOMIDE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    GELATIN (UNII: 2G86QN327L)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    SHELLAC (UNII: 46N107B71O)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITE (White opaque cap) , BLUE (Turquoise blue opaque body) Scoreno score
    ShapeCAPSULE (capsule) Size16mm
    FlavorImprint Code 1032
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1678-728 in 1 BOTTLE; Type 0: Not a Combination Product09/12/2022
    2NDC:70771-1678-1100 in 1 BOTTLE; Type 0: Not a Combination Product09/12/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21015409/12/2022
    LENALIDOMIDE 
    lenalidomide capsule
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1679
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LENALIDOMIDE (UNII: F0P408N6V4) (LENALIDOMIDE - UNII:F0P408N6V4) LENALIDOMIDE15 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    GELATIN (UNII: 2G86QN327L)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    SHELLAC (UNII: 46N107B71O)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITE (White opaque cap) , BLUE (Light Blue opaque body) Scoreno score
    ShapeCAPSULE (capsule) Size18mm
    FlavorImprint Code 1033
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1679-1100 in 1 BOTTLE; Type 0: Not a Combination Product09/12/2022
    2NDC:70771-1679-821 in 1 BOTTLE; Type 0: Not a Combination Product09/12/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21015409/12/2022
    LENALIDOMIDE 
    lenalidomide capsule
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1681
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LENALIDOMIDE (UNII: F0P408N6V4) (LENALIDOMIDE - UNII:F0P408N6V4) LENALIDOMIDE25 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    GELATIN (UNII: 2G86QN327L)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    SHELLAC (UNII: 46N107B71O)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITE (White opaque cap) , BLUE (Light Blue opaque body) Scoreno score
    ShapeCAPSULE (capsule) Size22mm
    FlavorImprint Code 1035
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1681-1100 in 1 BOTTLE; Type 0: Not a Combination Product09/12/2022
    2NDC:70771-1681-821 in 1 BOTTLE; Type 0: Not a Combination Product09/12/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21015409/12/2022
    Labeler - Zydus Lifesciences Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zydus Lifesciences Limited863362789ANALYSIS(70771-1677, 70771-1678, 70771-1679, 70771-1681) , MANUFACTURE(70771-1677, 70771-1678, 70771-1679, 70771-1681)