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Paliperidone ER Injection Prescribing Information

Package insert / product label
Generic name: paliperidone palmitate
Dosage form: injection, suspension
Drug class: Atypical antipsychotics

Medically reviewed by Drugs.com. Last updated on Jan 1, 2022.

PRINCIPAL DISPLAY PANEL

PALIPERIDONE PALMITATE
paliperidone palmitate kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:63646-711
Packaging
# Item Code Package Description
1 NDC:63646-711-39 1 KIT in 1 CARTON
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 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 Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PALIPERIDONE PALMITATE (PALIPERIDONE) PALIPERIDONE PALMITATE 39 mg in 0.25 mL
Inactive Ingredients
Ingredient Name Strength
POLYSORBATE 20
POLYETHYLENE GLYCOL 4000
CITRIC ACID MONOHYDRATE
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM
SODIUM HYDROXIDE
WATER
Packaging
# Item Code Package Description
1 NDC:63646-701-39 0.25 mL in 1 SYRINGE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Export only
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Export only 01/01/2022
PALIPERIDONE PALMITATE
paliperidone palmitate kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:63646-712
Packaging
# Item Code Package Description
1 NDC:63646-712-78 1 KIT in 1 CARTON
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 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 Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PALIPERIDONE PALMITATE (PALIPERIDONE) PALIPERIDONE PALMITATE 78 mg in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
POLYSORBATE 20
POLYETHYLENE GLYCOL 4000
CITRIC ACID MONOHYDRATE
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM
SODIUM HYDROXIDE
WATER
Packaging
# Item Code Package Description
1 NDC:63646-702-78 0.5 mL in 1 SYRINGE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Export only
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Export only 01/01/2022
PALIPERIDONE PALMITATE
paliperidone palmitate kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:63646-713
Packaging
# Item Code Package Description
1 NDC:63646-713-17 1 KIT in 1 CARTON
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 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 Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PALIPERIDONE PALMITATE (PALIPERIDONE) PALIPERIDONE PALMITATE 117 mg in 0.75 mL
Inactive Ingredients
Ingredient Name Strength
POLYSORBATE 20
POLYETHYLENE GLYCOL 4000
CITRIC ACID MONOHYDRATE
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM
SODIUM HYDROXIDE
WATER
Packaging
# Item Code Package Description
1 NDC:63646-703-17 0.75 mL in 1 SYRINGE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Export only
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Export only 01/01/2022
PALIPERIDONE PALMITATE
paliperidone palmitate kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:63646-710
Packaging
# Item Code Package Description
1 NDC:63646-710-56 1 KIT in 1 CARTON
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 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 Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PALIPERIDONE PALMITATE (PALIPERIDONE) PALIPERIDONE PALMITATE 156 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
POLYSORBATE 20
POLYETHYLENE GLYCOL 4000
CITRIC ACID MONOHYDRATE
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM
SODIUM HYDROXIDE
WATER
Packaging
# Item Code Package Description
1 NDC:63646-700-56 1 mL in 1 SYRINGE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Export only
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Export only 01/01/2022
PALIPERIDONE PALMITATE
paliperidone palmitate kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:63646-714
Packaging
# Item Code Package Description
1 NDC:63646-714-34 1 KIT in 1 CARTON
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 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 Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PALIPERIDONE PALMITATE (PALIPERIDONE) PALIPERIDONE PALMITATE 234 mg in 1.5 mL
Inactive Ingredients
Ingredient Name Strength
POLYSORBATE 20
POLYETHYLENE GLYCOL 4000
CITRIC ACID MONOHYDRATE
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM
SODIUM HYDROXIDE
WATER
Packaging
# Item Code Package Description
1 NDC:63646-704-34 1.5 mL in 1 SYRINGE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Export only
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Export only 01/01/2022
Labeler - TOLMAR Inc. (791156578)
Establishment
Name Address ID/FEI Operations
TOLMAR 1201 Cornerstone LLC 079112310 analysis(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)
TOLMAR Inc.

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