Label: DOXYCYCLINE capsule

  • NDC Code(s): 65841-821-01, 65841-821-05, 65841-821-06, 65841-821-10, view more
    65841-821-16, 65841-821-18, 65841-821-30, 65841-821-77, 65841-822-01, 65841-822-05, 65841-822-06, 65841-822-10, 65841-822-16, 65841-822-18, 65841-822-30, 65841-822-77, 65841-823-01, 65841-823-05, 65841-823-06, 65841-823-10, 65841-823-16, 65841-823-18, 65841-823-21, 65841-823-30, 65841-823-77
  • Packager: Zydus Lifesciences Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated August 25, 2022

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  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 65841-821-01 in bottle of 100 Capsules

    Doxycycline Capsules USP, 50 mg

    Rx Only

    100 Capsules

    Doxycycline Capsules 50 mg

    NDC 65841-822-01 in bottle of 100 Capsules

    Doxycycline Capsules USP, 75 mg

    Rx Only

    100 Capsules

    Doxycycline Capsules 75 mg

    NDC 65841-823-01 in bottle of 100 Capsules

    Doxycycline Capsules USP, 100 mg

    Rx Only

    100 Capsules

    Doxycycline Capsules 100 mg
  • INGREDIENTS AND APPEARANCE
    DOXYCYCLINE 
    doxycycline capsule
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-821
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOXYCYCLINE (UNII: N12000U13O) (DOXYCYCLINE ANHYDROUS - UNII:334895S862) DOXYCYCLINE ANHYDROUS50 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    GELATIN (UNII: 2G86QN327L)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHELLAC (UNII: 46N107B71O)  
    AMMONIA (UNII: 5138Q19F1X)  
    Product Characteristics
    ColorYELLOW (OPAQUE YELLOW) , WHITE (OPAQUE WHITE) Scoreno score
    ShapeCAPSULE (CAPSULE) Size16mm
    FlavorImprint Code 782
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-821-0630 in 1 BOTTLE; Type 0: Not a Combination Product03/14/2016
    2NDC:65841-821-1850 in 1 BOTTLE; Type 0: Not a Combination Product03/14/2016
    3NDC:65841-821-1690 in 1 BOTTLE; Type 0: Not a Combination Product03/14/2016
    4NDC:65841-821-01100 in 1 BOTTLE; Type 0: Not a Combination Product03/14/2016
    5NDC:65841-821-05500 in 1 BOTTLE; Type 0: Not a Combination Product03/14/2016
    6NDC:65841-821-101000 in 1 BOTTLE; Type 0: Not a Combination Product03/14/2016
    7NDC:65841-821-7710 in 1 CARTON03/14/2016
    7NDC:65841-821-3010 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20511503/14/2016
    DOXYCYCLINE 
    doxycycline capsule
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-822
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOXYCYCLINE (UNII: N12000U13O) (DOXYCYCLINE ANHYDROUS - UNII:334895S862) DOXYCYCLINE ANHYDROUS75 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    GELATIN (UNII: 2G86QN327L)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 3 (UNII: PN2ZH5LOQY)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHELLAC (UNII: 46N107B71O)  
    AMMONIA (UNII: 5138Q19F1X)  
    Product Characteristics
    ColorORANGE (OPAQUE ORANGE) , WHITE (OPAQUE WHITE) Scoreno score
    ShapeCAPSULE (CAPSULE) Size18mm
    FlavorImprint Code 706
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-822-0630 in 1 BOTTLE; Type 0: Not a Combination Product03/14/2016
    2NDC:65841-822-1850 in 1 BOTTLE; Type 0: Not a Combination Product03/14/2016
    3NDC:65841-822-1690 in 1 BOTTLE; Type 0: Not a Combination Product03/14/2016
    4NDC:65841-822-01100 in 1 BOTTLE; Type 0: Not a Combination Product03/14/2016
    5NDC:65841-822-05500 in 1 BOTTLE; Type 0: Not a Combination Product03/14/2016
    6NDC:65841-822-101000 in 1 BOTTLE; Type 0: Not a Combination Product03/14/2016
    7NDC:65841-822-7710 in 1 CARTON03/14/2016
    7NDC:65841-822-3010 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20511503/14/2016
    DOXYCYCLINE 
    doxycycline capsule
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-823
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOXYCYCLINE (UNII: N12000U13O) (DOXYCYCLINE ANHYDROUS - UNII:334895S862) DOXYCYCLINE ANHYDROUS100 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    GELATIN (UNII: 2G86QN327L)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 3 (UNII: PN2ZH5LOQY)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHELLAC (UNII: 46N107B71O)  
    AMMONIA (UNII: 5138Q19F1X)  
    Product Characteristics
    ColorYELLOW (OPAQUE YELLOW) , ORANGE (OPAQUE ORANGE) Scoreno score
    ShapeCAPSULE (CAPSULE) Size19mm
    FlavorImprint Code 707
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-823-0630 in 1 BOTTLE; Type 0: Not a Combination Product03/14/2016
    2NDC:65841-823-1850 in 1 BOTTLE; Type 0: Not a Combination Product03/14/2016
    3NDC:65841-823-1690 in 1 BOTTLE; Type 0: Not a Combination Product03/14/2016
    4NDC:65841-823-01100 in 1 BOTTLE; Type 0: Not a Combination Product03/14/2016
    5NDC:65841-823-21250 in 1 BOTTLE; Type 0: Not a Combination Product03/14/2016
    6NDC:65841-823-05500 in 1 BOTTLE; Type 0: Not a Combination Product03/14/2016
    7NDC:65841-823-101000 in 1 BOTTLE; Type 0: Not a Combination Product03/14/2016
    8NDC:65841-823-7710 in 1 CARTON03/14/2016
    8NDC:65841-823-3010 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20511503/14/2016
    Labeler - Zydus Lifesciences Limited (918596198)
    Registrant - Zydus Lifesciences Limited (863362789)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zydus Lifesciences Limited863362789ANALYSIS(65841-821, 65841-822, 65841-823) , MANUFACTURE(65841-821, 65841-822, 65841-823)
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