PALIPERIDONE PALMITATE- paliperidone palmitate 
TOLMAR Inc.

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Paliperidone Palmitate Extended-Release Injectable Suspension

PRINCIPAL DISPLAY PANEL

 39 mg

78 mg
117mg
156mg
234mg
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)

Revised: 1/2022
Document Id: 864ae535-dd76-43d3-a612-920416bbaae8
Set id: a08ab93b-0bac-42fd-8357-d10a49301b72
Version: 4
Effective Time: 20220114
 
TOLMAR Inc.