Label: CLINDAMYCIN HYDROCHLORIDE capsule, gelatin coated

  • NDC Code(s): 70771-1136-1, 70771-1136-5, 70771-1136-8, 70771-1137-1, view more
    70771-1137-5, 70771-1137-8, 70771-1183-1, 70771-1183-5, 70771-1183-8
  • 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 70771-1136-1 in bottle of 100 Capsules

    Clindamycin Hydrochloride Capsules USP, 75 mg

    Rx only

    100 Capsules

    Clindamycin HCL Capsules USP, 75 mg

    NDC 70771-1137-1 in bottle of 100 Capsules

    Clindamycin Hydrochloride Capsules USP, 150 mg

    Rx only

    100 Capsules

    Clindamycin HCL Capsules USP, 150 mg

    NDC 70771-1183-1 in bottle of 100 Capsules

    Clindamycin Hydrochloride Capsules USP, 300 mg

    Rx only

    100 Capsules

    Clindamycin HCL Capsules USP, 300 mg
  • INGREDIENTS AND APPEARANCE
    CLINDAMYCIN HYDROCHLORIDE 
    clindamycin hydrochloride capsule, gelatin coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1136
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CLINDAMYCIN HYDROCHLORIDE (UNII: T20OQ1YN1W) (CLINDAMYCIN - UNII:3U02EL437C) CLINDAMYCIN75 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 3 (UNII: PN2ZH5LOQY)  
    GELATIN (UNII: 2G86QN327L)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorBLUE (BLUE (CAP)) , BLUE (BLUE (BODY)) Scoreno score
    ShapeCAPSULE (CAPSULE) Size18mm
    FlavorImprint Code Z;89
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1136-816 in 1 BOTTLE; Type 0: Not a Combination Product11/23/2017
    2NDC:70771-1136-1100 in 1 BOTTLE; Type 0: Not a Combination Product11/23/2017
    3NDC:70771-1136-5500 in 1 BOTTLE; Type 0: Not a Combination Product11/23/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA06521711/17/2017
    CLINDAMYCIN HYDROCHLORIDE 
    clindamycin hydrochloride capsule, gelatin coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1137
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CLINDAMYCIN HYDROCHLORIDE (UNII: T20OQ1YN1W) (CLINDAMYCIN - UNII:3U02EL437C) CLINDAMYCIN150 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 3 (UNII: PN2ZH5LOQY)  
    GELATIN (UNII: 2G86QN327L)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorBLUE (BLUE (CAP)) , BLUE (BLUE (BODY)) Scoreno score
    ShapeCAPSULE (CAPSULE) Size20mm
    FlavorImprint Code Z;90
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1137-816 in 1 BOTTLE; Type 0: Not a Combination Product11/23/2017
    2NDC:70771-1137-1100 in 1 BOTTLE; Type 0: Not a Combination Product11/23/2017
    3NDC:70771-1137-5500 in 1 BOTTLE; Type 0: Not a Combination Product11/23/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA06521711/23/2017
    CLINDAMYCIN HYDROCHLORIDE 
    clindamycin hydrochloride capsule, gelatin coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1183
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CLINDAMYCIN HYDROCHLORIDE (UNII: T20OQ1YN1W) (CLINDAMYCIN - UNII:3U02EL437C) CLINDAMYCIN300 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 3 (UNII: PN2ZH5LOQY)  
    GELATIN (UNII: 2G86QN327L)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorBLUE (BLUE (CAP)) , BLUE (BLUE (BODY)) Scoreno score
    ShapeCAPSULE (CAPSULE) Size21mm
    FlavorImprint Code Z;91
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1183-816 in 1 BOTTLE; Type 0: Not a Combination Product11/23/2017
    2NDC:70771-1183-1100 in 1 BOTTLE; Type 0: Not a Combination Product11/23/2017
    3NDC:70771-1183-5500 in 1 BOTTLE; Type 0: Not a Combination Product11/23/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA06521711/23/2017
    Labeler - Zydus Lifesciences Limited (918596198)
    Registrant - Zydus Lifesciences Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zydus Lifesciences Limited918596198ANALYSIS(70771-1136, 70771-1137, 70771-1183) , MANUFACTURE(70771-1136, 70771-1137, 70771-1183)
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