Label: ZIPRASIDONE capsule

  • NDC Code(s): 70771-1179-2, 70771-1179-5, 70771-1179-6, 70771-1179-8, view more
    70771-1180-2, 70771-1180-5, 70771-1180-6, 70771-1180-8, 70771-1181-2, 70771-1181-5, 70771-1181-6, 70771-1181-8, 70771-1182-2, 70771-1182-5, 70771-1182-6, 70771-1182-8
  • Packager: Cadila Healthcare Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated September 24, 2020

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 70771-1179-6

    Ziprasidone capsules, 20 mg

    60 Capsules

    Rx only

    image

    NDC 70771-1180-6

    Ziprasidone capsules, 40 mg

    60 Capsules

    Rx only

    Image

    NDC 70771-1181-6

    Ziprasidone capsules, 60 mg

    60 Capsules

    Rx only

    Image

    NDC 70771-1182-6

    Ziprasidone capsules, 80 mg

    60 Capsules

    Rx only

    Image
  • INGREDIENTS AND APPEARANCE
    ZIPRASIDONE 
    ziprasidone capsule
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1179
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZIPRASIDONE HYDROCHLORIDE (UNII: 216X081ORU) (ZIPRASIDONE - UNII:6UKA5VEJ6X) ZIPRASIDONE20 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GELATIN (UNII: 2G86QN327L)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHELLAC (UNII: 46N107B71O)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorBLUE (DARK BLUE OPAQUE CAP) , WHITE (WHITE OPAQUE BODY) Scoreno score
    ShapeCAPSULE (CAPSULE) Size14mm
    FlavorImprint Code 237
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1179-660 in 1 BOTTLE; Type 0: Not a Combination Product12/28/2017
    2NDC:70771-1179-5500 in 1 BOTTLE; Type 0: Not a Combination Product12/28/2017
    3NDC:70771-1179-88 in 1 CARTON12/28/2017
    3NDC:70771-1179-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20898812/28/2017
    ZIPRASIDONE 
    ziprasidone capsule
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1180
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZIPRASIDONE HYDROCHLORIDE (UNII: 216X081ORU) (ZIPRASIDONE - UNII:6UKA5VEJ6X) ZIPRASIDONE80 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GELATIN (UNII: 2G86QN327L)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHELLAC (UNII: 46N107B71O)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorBLUE (DARK BLUE OPAQUE CAP) , BLUE (LIGHT BLUE OPAQUE BODY) Scoreno score
    ShapeCAPSULESize19mm
    FlavorImprint Code 240
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1180-660 in 1 BOTTLE; Type 0: Not a Combination Product12/28/2017
    2NDC:70771-1180-5500 in 1 BOTTLE; Type 0: Not a Combination Product12/28/2017
    3NDC:70771-1180-88 in 1 CARTON12/28/2017
    3NDC:70771-1180-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20898812/28/2017
    ZIPRASIDONE 
    ziprasidone capsule
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1181
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZIPRASIDONE HYDROCHLORIDE (UNII: 216X081ORU) (ZIPRASIDONE - UNII:6UKA5VEJ6X) ZIPRASIDONE60 mg
    Inactive Ingredients
    Ingredient NameStrength
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    GELATIN (UNII: 2G86QN327L)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHELLAC (UNII: 46N107B71O)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITE (WHITE OPAQUE CAP) , WHITE (WHITE OPAQUE BODY) Scoreno score
    ShapeCAPSULE (CAPSULE) Size18mm
    FlavorImprint Code 239
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1181-660 in 1 BOTTLE; Type 0: Not a Combination Product12/28/2017
    2NDC:70771-1181-5500 in 1 BOTTLE; Type 0: Not a Combination Product12/28/2017
    3NDC:70771-1181-88 in 1 CARTON12/28/2017
    3NDC:70771-1181-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20898812/28/2017
    ZIPRASIDONE 
    ziprasidone capsule
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1182
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZIPRASIDONE HYDROCHLORIDE (UNII: 216X081ORU) (ZIPRASIDONE - UNII:6UKA5VEJ6X) ZIPRASIDONE40 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GELATIN (UNII: 2G86QN327L)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHELLAC (UNII: 46N107B71O)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorBLUE (DARK BLUE OPAQUE CAP) , BLUE (LIGHT BLUE OPAQUE BODY) Scoreno score
    ShapeCAPSULE (CAPSULE) Size16mm
    FlavorImprint Code 238
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1182-660 in 1 BOTTLE; Type 0: Not a Combination Product12/28/2017
    2NDC:70771-1182-5500 in 1 BOTTLE; Type 0: Not a Combination Product12/28/2017
    3NDC:70771-1182-88 in 1 CARTON12/28/2017
    3NDC:70771-1182-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20898812/28/2017
    Labeler - Cadila Healthcare Limited (918596198)
    Registrant - Cadila Healthcare Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited863362789ANALYSIS(70771-1179, 70771-1180, 70771-1181, 70771-1182) , MANUFACTURE(70771-1179, 70771-1180, 70771-1181, 70771-1182)