Label: HALOPERIDOL tablet

  • NDC Code(s): 65841-626-01, 65841-626-10, 65841-627-01, 65841-627-10, view more
    65841-628-01, 65841-628-06
  • Packager: Cadila Healthcare Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated July 28, 2020

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  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 65841-626-01 in bottle of 100 Tablets

    Haloperidol Tablets USP, 5 mg

    Rx only

    100 Tablets

    Haloperidol Tabs5mg

    NDC 65841-627-01 in bottles of 100 tablets

    Haloperidol Tablets USP, 10 mg

    Rx only

    100 Tablets

    Haloperidol Tabs10mg

    NDC 65841-628-01 in bottles of 100 tablets

    Haloperidol Tablets USP, 20 mg

    Rx only

    100 Tablets

    Haloperidol Tabs20mg
  • INGREDIENTS AND APPEARANCE
    HALOPERIDOL 
    haloperidol tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-626
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HALOPERIDOL (UNII: J6292F8L3D) (HALOPERIDOL - UNII:J6292F8L3D) HALOPERIDOL5 mg
    Inactive Ingredients
    Ingredient NameStrength
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    CALCIUM STEARATE (UNII: 776XM7047L)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    FD&C BLUE NO. 1--ALUMINUM LAKE (UNII: J9EQA3S2JM)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorGREEN (GREEN) Score2 pieces
    ShapeOVAL (CAPSULE) Size10mm
    FlavorImprint Code ZC;07
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-626-01100 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2008
    2NDC:65841-626-101000 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2008
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07758001/03/2008
    HALOPERIDOL 
    haloperidol tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-627
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HALOPERIDOL (UNII: J6292F8L3D) (HALOPERIDOL - UNII:J6292F8L3D) HALOPERIDOL10 mg
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM STEARATE (UNII: 776XM7047L)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    FD&C BLUE NO. 1--ALUMINUM LAKE (UNII: J9EQA3S2JM)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    Product Characteristics
    ColorGREEN (LIGHT GREEN) Score2 pieces
    ShapeOVAL (CAPSULE) Size10mm
    FlavorImprint Code ZC;08
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-627-01100 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2008
    2NDC:65841-627-101000 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2008
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07758001/03/2008
    HALOPERIDOL 
    haloperidol tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-628
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HALOPERIDOL (UNII: J6292F8L3D) (HALOPERIDOL - UNII:J6292F8L3D) HALOPERIDOL20 mg
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM STEARATE (UNII: 776XM7047L)  
    D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorORANGE (CORAL) Score2 pieces
    ShapeOVAL (CAPSULE) Size10mm
    FlavorImprint Code ZC;09
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-628-01100 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2008
    2NDC:65841-628-0630 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2008
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07758001/03/2008
    Labeler - Cadila Healthcare Limited (918596198)
    Registrant - Cadila Healthcare Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited918596198ANALYSIS(65841-626, 65841-627, 65841-628) , MANUFACTURE(65841-626, 65841-627, 65841-628)
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