Label: DOXYCYCLINE HYCLATE tablet

  • NDC Code(s): 70771-1104-0, 70771-1104-1, 70771-1104-2, 70771-1104-4, view more
    70771-1104-5, 70771-1104-7
  • Packager: Cadila Healthcare Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated April 21, 2020

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

  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 70771-1104-7

    Doxycycline Hyclate Tablets, 100 mg

    Rx only

    50 tablets

    Doxycycline hyclate tablets
  • INGREDIENTS AND APPEARANCE
    DOXYCYCLINE HYCLATE 
    doxycycline hyclate tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1104
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOXYCYCLINE HYCLATE (UNII: 19XTS3T51U) (DOXYCYCLINE ANHYDROUS - UNII:334895S862) DOXYCYCLINE ANHYDROUS100 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorYELLOW (BEIGE COLORED) Scoreno score
    ShapeROUND (BICONVEX) Size9mm
    FlavorImprint Code D77
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1104-750 in 1 BOTTLE; Type 0: Not a Combination Product04/02/2018
    2NDC:70771-1104-1100 in 1 BOTTLE; Type 0: Not a Combination Product04/02/2018
    3NDC:70771-1104-01000 in 1 BOTTLE; Type 0: Not a Combination Product04/02/2018
    4NDC:70771-1104-5500 in 1 BOTTLE; Type 0: Not a Combination Product04/02/2018
    5NDC:70771-1104-410 in 1 CARTON04/02/2018
    5NDC:70771-1104-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20777304/02/2018
    Labeler - Cadila Healthcare Limited (918596198)
    Registrant - Cadila Healthcare Limited (863362789)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited863362789ANALYSIS(70771-1104) , MANUFACTURE(70771-1104)