Label: DOXYCYCLINE HYCLATE capsule

  • NDC Code(s): 70771-1358-0, 70771-1358-1, 70771-1358-2, 70771-1358-4, view more
    70771-1358-5, 70771-1358-7, 70771-1359-0, 70771-1359-1, 70771-1359-2, 70771-1359-4, 70771-1359-5, 70771-1359-7
  • Packager: Zydus Lifesciences Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated August 16, 2024

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  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 70771-1358-7

    Doxycycline hyclate capsules, 50 mg

    Rx only

    50 capsules

    Doxycycline hyclate capsules

    NDC 70771-1359-7

    Doxycycline hyclate capsules, 100 mg

    Rx only

    50 capsules

    Doxycycline hyclate capsules
  • INGREDIENTS AND APPEARANCE
    DOXYCYCLINE HYCLATE 
    doxycycline hyclate capsule
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1358
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOXYCYCLINE HYCLATE (UNII: 19XTS3T51U) (DOXYCYCLINE ANHYDROUS - UNII:334895S862) DOXYCYCLINE ANHYDROUS50 mg
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    AMMONIA (UNII: 5138Q19F1X)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
    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)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHELLAC (UNII: 46N107B71O)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorBLUE (BLUE) , WHITE (WHITE) Scoreno score
    ShapeCAPSULE (CAPSULE) Size16mm
    FlavorImprint Code CHL;D75
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1358-750 in 1 BOTTLE; Type 0: Not a Combination Product09/12/2018
    2NDC:70771-1358-1100 in 1 BOTTLE; Type 0: Not a Combination Product09/12/2018
    3NDC:70771-1358-5500 in 1 BOTTLE; Type 0: Not a Combination Product09/12/2018
    4NDC:70771-1358-01000 in 1 BOTTLE; Type 0: Not a Combination Product09/12/2018
    5NDC:70771-1358-410 in 1 CARTON09/12/2018
    5NDC:70771-1358-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20777409/12/2018
    DOXYCYCLINE HYCLATE 
    doxycycline hyclate capsule
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1359
    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
    ALCOHOL (UNII: 3K9958V90M)  
    AMMONIA (UNII: 5138Q19F1X)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
    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)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHELLAC (UNII: 46N107B71O)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorBLUE (LIGHT BLUE) , BLUE (LIGHT BLUE) Scoreno score
    ShapeCAPSULE (CAPSULE) Size20mm
    FlavorImprint Code CHL;D76
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1359-750 in 1 BOTTLE; Type 0: Not a Combination Product09/12/2018
    2NDC:70771-1359-1100 in 1 BOTTLE; Type 0: Not a Combination Product09/12/2018
    3NDC:70771-1359-5500 in 1 BOTTLE; Type 0: Not a Combination Product09/12/2018
    4NDC:70771-1359-01000 in 1 BOTTLE; Type 0: Not a Combination Product09/12/2018
    5NDC:70771-1359-410 in 1 CARTON09/12/2018
    5NDC:70771-1359-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20777409/12/2018
    Labeler - Zydus Lifesciences Limited (918596198)
    Registrant - Zydus Lifesciences Limited (863362789)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zydus Lifesciences Limited863362789ANALYSIS(70771-1358, 70771-1359) , MANUFACTURE(70771-1358, 70771-1359)
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