Label: PALIPERIDONE PALMITATE kit

  • NDC Code(s): 63646-700-56, 63646-701-39, 63646-702-78, 63646-703-17, view more
    63646-704-34, 63646-710-56, 63646-711-39, 63646-712-78, 63646-713-17, 63646-714-34
  • Packager: TOLMAR Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL

Drug Label Information

Updated January 14, 2022

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • PRINCIPAL DISPLAY PANEL

     39 mg

    78 mg
    117mg
    156mg
    234mg
  • INGREDIENTS AND APPEARANCE
    PALIPERIDONE PALMITATE 
    paliperidone palmitate kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:63646-711
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63646-711-391 in 1 CARTON; Type 0: Not a Combination Product01/01/2022
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 SYRINGE 0.25 mL
    Part 1 of 1
    PALIPERIDONE PALMITATE 
    paliperidone palmitate injection, suspension, extended release
    Product Information
    Item Code (Source)NDC:63646-701
    Route of AdministrationINTRAMUSCULAR
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PALIPERIDONE PALMITATE (UNII: R8P8USM8FR) (PALIPERIDONE - UNII:838F01T721) PALIPERIDONE PALMITATE39 mg  in 0.25 mL
    Inactive Ingredients
    Ingredient NameStrength
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63646-701-390.25 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Export only
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Export only01/01/2022
    PALIPERIDONE PALMITATE 
    paliperidone palmitate kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:63646-712
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63646-712-781 in 1 CARTON; Type 0: Not a Combination Product01/01/2022
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 SYRINGE 0.5 mL
    Part 1 of 1
    PALIPERIDONE PALMITATE 
    paliperidone palmitate injection, suspension, extended release
    Product Information
    Item Code (Source)NDC:63646-702
    Route of AdministrationINTRAMUSCULAR
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PALIPERIDONE PALMITATE (UNII: R8P8USM8FR) (PALIPERIDONE - UNII:838F01T721) PALIPERIDONE PALMITATE78 mg  in 0.5 mL
    Inactive Ingredients
    Ingredient NameStrength
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63646-702-780.5 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Export only
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Export only01/01/2022
    PALIPERIDONE PALMITATE 
    paliperidone palmitate kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:63646-713
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63646-713-171 in 1 CARTON; Type 0: Not a Combination Product01/01/2022
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 SYRINGE 0.75 mL
    Part 1 of 1
    PALIPERIDONE PALMITATE 
    paliperidone palmitate injection, suspension, extended release
    Product Information
    Item Code (Source)NDC:63646-703
    Route of AdministrationINTRAMUSCULAR
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PALIPERIDONE PALMITATE (UNII: R8P8USM8FR) (PALIPERIDONE - UNII:838F01T721) PALIPERIDONE PALMITATE117 mg  in 0.75 mL
    Inactive Ingredients
    Ingredient NameStrength
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63646-703-170.75 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Export only
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Export only01/01/2022
    PALIPERIDONE PALMITATE 
    paliperidone palmitate kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:63646-710
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63646-710-561 in 1 CARTON; Type 0: Not a Combination Product01/01/2022
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 SYRINGE 1 mL
    Part 1 of 1
    PALIPERIDONE PALMITATE 
    paliperidone palmitate injection, suspension, extended release
    Product Information
    Item Code (Source)NDC:63646-700
    Route of AdministrationINTRAMUSCULAR
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PALIPERIDONE PALMITATE (UNII: R8P8USM8FR) (PALIPERIDONE - UNII:838F01T721) PALIPERIDONE PALMITATE156 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63646-700-561 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Export only
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Export only01/01/2022
    PALIPERIDONE PALMITATE 
    paliperidone palmitate kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:63646-714
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63646-714-341 in 1 CARTON; Type 0: Not a Combination Product01/01/2022
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 SYRINGE 1.5 mL
    Part 1 of 1
    PALIPERIDONE PALMITATE 
    paliperidone palmitate injection, suspension, extended release
    Product Information
    Item Code (Source)NDC:63646-704
    Route of AdministrationINTRAMUSCULAR
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PALIPERIDONE PALMITATE (UNII: R8P8USM8FR) (PALIPERIDONE - UNII:838F01T721) PALIPERIDONE PALMITATE234 mg  in 1.5 mL
    Inactive Ingredients
    Ingredient NameStrength
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63646-704-341.5 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Export only
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Export only01/01/2022
    Labeler - TOLMAR Inc. (791156578)
    Establishment
    NameAddressID/FEIBusiness Operations
    TOLMAR 1201 Cornerstone LLC079112310analysis(63646-711, 63646-701, 63646-712, 63646-702, 63646-713, 63646-703, 63646-710, 63646-700, 63646-714, 63646-704) , label(63646-711, 63646-701, 63646-712, 63646-702, 63646-713, 63646-703, 63646-710, 63646-700, 63646-714, 63646-704) , manufacture(63646-711, 63646-701, 63646-712, 63646-702, 63646-713, 63646-703, 63646-710, 63646-700, 63646-714, 63646-704) , pack(63646-711, 63646-701, 63646-712, 63646-702, 63646-713, 63646-703, 63646-710, 63646-700, 63646-714, 63646-704)