AZATHIOPRINE TABLET [CADILA HEALTHCARE LIMITED]

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AZATHIOPRINE TABLET [CADILA HEALTHCARE LIMITED]
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NDC 70771-1139-1, 70771-1139-5, 70771-1140-1, 70771-1140-5, 70771-1141-1, 70771-1141-5
Set ID 89b272f0-ef5c-49e4-820f-fcd7ea8ef066
Category HUMAN PRESCRIPTION DRUG LABEL
Packager Cadila Healthcare Limited
Generic Name
Product Class
Product Number
Application Number ANDA077621
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  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 70771-1140-1 in bottle of 100 tablets

    Azathioprine Tablets USP, 75 mg

    100 tablets

    Rx only

    75 mg label

    75 mg label

  • PRINCIPAL DISPLAY PANEL

    NDC 70771-1141-1 in bottle of 100 tablets

    Azathioprine Tablets USP, 100 mg

    100 tablets

    Rx only

    100 mg label

    100 mg label

  • PRINCIPAL DISPLAY PANEL

    NDC 70771-1139-1 in bottle of 100 tablets

    Azathioprine Tablets USP, 25 mg

    100 tablets

    Rx only

    25 mg label

    25 mg label

  • INGREDIENTS AND APPEARANCE
    AZATHIOPRINE 
    azathioprine tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1139
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AZATHIOPRINE (UNII: MRK240IY2L) (AZATHIOPRINE - UNII:MRK240IY2L) AZATHIOPRINE25 
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorYELLOW (YELLOW) Score2 pieces
    ShapeROUND (ROUND) Size6mm
    FlavorImprint Code ZD;11
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1139-1100 in 1 BOTTLE; Type 0: Not a Combination Product12/02/2017
    2NDC:70771-1139-5500 in 1 BOTTLE; Type 0: Not a Combination Product12/02/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07762112/02/2017
    AZATHIOPRINE 
    azathioprine tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1140
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AZATHIOPRINE (UNII: MRK240IY2L) (AZATHIOPRINE - UNII:MRK240IY2L) AZATHIOPRINE75 
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorYELLOW (YELLOW) Score2 pieces
    ShapeROUND (ROUND) Size9mm
    FlavorImprint Code ZD;10
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1140-1100 in 1 BOTTLE; Type 0: Not a Combination Product12/02/2017
    2NDC:70771-1140-5500 in 1 BOTTLE; Type 0: Not a Combination Product12/02/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07762112/02/2017
    AZATHIOPRINE 
    azathioprine tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1141
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AZATHIOPRINE (UNII: MRK240IY2L) (AZATHIOPRINE - UNII:MRK240IY2L) AZATHIOPRINE100 
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorYELLOW (YELLOW) Score2 pieces
    ShapeROUND (ROUND) Size10mm
    FlavorImprint Code ZD;09
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1141-1100 in 1 BOTTLE; Type 0: Not a Combination Product12/02/2017
    2NDC:70771-1141-5500 in 1 BOTTLE; Type 0: Not a Combination Product12/02/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07762112/02/2017
    Labeler - Cadila Healthcare Limited (918596198)
    Registrant - Cadila Healthcare Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited918596198ANALYSIS(70771-1139, 70771-1140, 70771-1141) , MANUFACTURE(70771-1139, 70771-1140, 70771-1141)
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