Paliperidone ER Injection: Package Insert / Prescribing Info

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

Medically reviewed by Drugs.com. Last updated on Mar 1, 2024.

PRINCIPAL DISPLAY PANEL

39 mg

PALIPERIDONE PALMITATE
paliperidone palmitate kit

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:63646-711

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63646-711-39	1 in 1 CARTON; Type 0: Not a Combination Product	01/01/2022

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PALIPERIDONE PALMITATE (UNII: R8P8USM8FR) (PALIPERIDONE - UNII:838F01T721)	PALIPERIDONE PALMITATE	39 mg in 0.25 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63646-701-39	0.25 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Export only

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Export only		01/01/2022

PALIPERIDONE PALMITATE
paliperidone palmitate kit

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:63646-712

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63646-712-78	1 in 1 CARTON; Type 0: Not a Combination Product	01/01/2022

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PALIPERIDONE PALMITATE (UNII: R8P8USM8FR) (PALIPERIDONE - UNII:838F01T721)	PALIPERIDONE PALMITATE	78 mg in 0.5 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63646-702-78	0.5 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Export only

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Export only		01/01/2022

PALIPERIDONE PALMITATE
paliperidone palmitate kit

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:63646-713

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63646-713-17	1 in 1 CARTON; Type 0: Not a Combination Product	01/01/2022

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PALIPERIDONE PALMITATE (UNII: R8P8USM8FR) (PALIPERIDONE - UNII:838F01T721)	PALIPERIDONE PALMITATE	117 mg in 0.75 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63646-703-17	0.75 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Export only

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Export only		01/01/2022

PALIPERIDONE PALMITATE
paliperidone palmitate kit

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:63646-710

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63646-710-56	1 in 1 CARTON; Type 0: Not a Combination Product	01/01/2022

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PALIPERIDONE PALMITATE (UNII: R8P8USM8FR) (PALIPERIDONE - UNII:838F01T721)	PALIPERIDONE PALMITATE	156 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63646-700-56	1 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Export only

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Export only		01/01/2022

PALIPERIDONE PALMITATE
paliperidone palmitate kit

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:63646-714

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63646-714-34	1 in 1 CARTON; Type 0: Not a Combination Product	01/01/2022

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PALIPERIDONE PALMITATE (UNII: R8P8USM8FR) (PALIPERIDONE - UNII:838F01T721)	PALIPERIDONE PALMITATE	234 mg in 1.5 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63646-704-34	1.5 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Export only

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Export only		01/01/2022

Labeler - TOLMAR Inc. (791156578)

Name	Address	ID/FEI	Business Operations
Establishment
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)