Label: DOXYCYCLINE HYCLATE tablet, delayed release

  • NDC Code(s): 70771-1587-1, 70771-1587-2, 70771-1587-4, 70771-1587-5, view more
    70771-1587-6, 70771-1588-1, 70771-1588-2, 70771-1588-4, 70771-1588-5, 70771-1588-6, 70771-1589-1, 70771-1589-2, 70771-1589-4, 70771-1589-5, 70771-1589-6
  • Packager: Zydus Lifesciences Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 13, 2022

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  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 70771-1587-6 in bottle of 60 tablets

    Doxycycline Hyclate Delayed-release Tablets USP, 75 mg

    Rx only

    60 tablets

    75 mg label

    NDC 70771-1588-6 in bottle of 60 tablets

    Doxycycline Hyclate Delayed-release Tablets USP, 100 mg

    Rx only

    60 tablets

    100 mg label

    NDC 70771-1589-6 in bottle of 60 tablets

    Doxycycline Hyclate Delayed-release Tablets USP, 150 mg

    Rx only

    60 tablets

    150 mg label
  • INGREDIENTS AND APPEARANCE
    DOXYCYCLINE HYCLATE 
    doxycycline hyclate tablet, delayed release
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1587
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOXYCYCLINE HYCLATE (UNII: 19XTS3T51U) (DOXYCYCLINE ANHYDROUS - UNII:334895S862) DOXYCYCLINE ANHYDROUS75 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST) (UNII: 87Y6436BKR)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) Score2 pieces
    ShapeOVAL (OVAL) Size16mm
    FlavorImprint Code 70;8
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1587-660 in 1 BOTTLE; Type 0: Not a Combination Product12/21/2018
    2NDC:70771-1587-1100 in 1 BOTTLE; Type 0: Not a Combination Product12/21/2018
    3NDC:70771-1587-5500 in 1 BOTTLE; Type 0: Not a Combination Product12/21/2018
    4NDC:70771-1587-410 in 1 CARTON12/21/2018
    4NDC:70771-1587-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20677212/21/2018
    DOXYCYCLINE HYCLATE 
    doxycycline hyclate tablet, delayed release
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1588
    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)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST) (UNII: 87Y6436BKR)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) Score2 pieces
    ShapeOVAL (OVAL) Size18mm
    FlavorImprint Code 70;9
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1588-660 in 1 BOTTLE; Type 0: Not a Combination Product12/21/2018
    2NDC:70771-1588-1100 in 1 BOTTLE; Type 0: Not a Combination Product12/21/2018
    3NDC:70771-1588-5500 in 1 BOTTLE; Type 0: Not a Combination Product12/21/2018
    4NDC:70771-1588-410 in 1 CARTON12/21/2018
    4NDC:70771-1588-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20677212/21/2018
    DOXYCYCLINE HYCLATE 
    doxycycline hyclate tablet, delayed release
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1589
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOXYCYCLINE HYCLATE (UNII: 19XTS3T51U) (DOXYCYCLINE ANHYDROUS - UNII:334895S862) DOXYCYCLINE ANHYDROUS150 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST) (UNII: 87Y6436BKR)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) Score3 pieces
    ShapeCAPSULE (CAPSULE) Size19mm
    FlavorImprint Code 7;1;0
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1589-660 in 1 BOTTLE; Type 0: Not a Combination Product12/21/2018
    2NDC:70771-1589-1100 in 1 BOTTLE; Type 0: Not a Combination Product12/21/2018
    3NDC:70771-1589-5500 in 1 BOTTLE; Type 0: Not a Combination Product12/21/2018
    4NDC:70771-1589-410 in 1 CARTON12/21/2018
    4NDC:70771-1589-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20677212/21/2018
    Labeler - Zydus Lifesciences Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zydus Lifesciences Limited863362789ANALYSIS(70771-1587, 70771-1588, 70771-1589) , MANUFACTURE(70771-1587, 70771-1588, 70771-1589)
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