ITRACONAZOLE CAPSULE [CADILA HEALTHCARE LIMITED]

ITRACONAZOLE CAPSULE [CADILA HEALTHCARE LIMITED]
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NDC 70771-1208-0, 70771-1208-1, 70771-1208-2, 70771-1208-3, 70771-1208-4
Set ID a545b2bd-ef19-4d0d-b7f6-c695173eaa3c
Category HUMAN PRESCRIPTION DRUG LABEL
Packager Cadila Healthcare Limited
Generic Name
Product Class Azole Antifungal
Product Number
Application Number ANDA204672
  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Itraconazole Capsules, 100 mg

    NDC 70771-1208-3

    30 Capsules

    Itraconazole Capsules
  • INGREDIENTS AND APPEARANCE
    ITRACONAZOLE 
    itraconazole capsule
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1208
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ITRACONAZOLE (UNII: 304NUG5GF4) (ITRACONAZOLE - UNII:304NUG5GF4) ITRACONAZOLE100 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 3 (UNII: PN2ZH5LOQY)  
    GELATIN (UNII: 2G86QN327L)  
    HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SUCROSE (UNII: C151H8M554)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
    ALCOHOL (UNII: 3K9958V90M)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SHELLAC (UNII: 46N107B71O)  
    AMMONIA (UNII: 5138Q19F1X)  
    POLOXAMER 188 (UNII: LQA7B6G8JG)  
    Product Characteristics
    ColorBLUE (BLUE) Scoreno score
    ShapeCAPSULE (CAPSULE) Size23mm
    FlavorImprint Code ZA;65;100;mg
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1208-1100 in 1 BOTTLE; Type 0: Not a Combination Product03/06/2018
    2NDC:70771-1208-01000 in 1 BOTTLE; Type 0: Not a Combination Product03/06/2018
    3NDC:70771-1208-410 in 1 CARTON03/06/2018
    3NDC:70771-1208-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    4NDC:70771-1208-330 in 1 BOTTLE; Type 0: Not a Combination Product03/06/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20467203/06/2018
    Labeler - Cadila Healthcare Limited (918596198)
    Registrant - Cadila Healthcare Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited918596198ANALYSIS(70771-1208) , MANUFACTURE(70771-1208)

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