FDA.reportPublic FDA data

Paliperidone Palmitate Extended-Release Injectable Suspension

Manufacturer
TOLMAR Inc.
Effective date
2026-03-23
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-05-31 22:11:01

Label at a glance#

ProductPaliperidone Palmitate
Active ingredientPALIPERIDONE PALMITATE
Label structure1 sections

Label contents#

Full prescribing information#

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

 39 mg39 mg

78 mg
78 mg
117mg
117mg
156mg
156mg
234mg
234mg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
858056paliperidone palmitate 117 MG in 0.75 ML Prefilled SyringePSN6
858054paliperidone palmitate 156 MG in 1 ML Prefilled SyringePSN6
858052paliperidone palmitate 234 MG in 1.5 ML Prefilled SyringePSN6
858073paliperidone palmitate 39 MG in 0.25 ML Prefilled SyringePSN6
858048paliperidone palmitate 78 MG in 0.5 ML Prefilled SyringePSN6
8580730.25 ML paliperidone palmitate 156 MG/ML Prefilled SyringeSCD6
8580480.5 ML paliperidone palmitate 156 MG/ML Prefilled SyringeSCD6
8580560.75 ML paliperidone palmitate 156 MG/ML Prefilled SyringeSCD6
8580541 ML paliperidone palmitate 156 MG/ML Prefilled SyringeSCD6
8580521.5 ML paliperidone palmitate 156 MG/ML Prefilled SyringeSCD6
858056paliperidone palmitate 117 MG per 0.75 ML Prefilled SyringeSY6
858054paliperidone palmitate 156 MG per 1 ML Prefilled SyringeSY6
858052paliperidone palmitate 234 MG per 1.5 ML Prefilled SyringeSY6
858073paliperidone palmitate 39 MG per 0.25 ML Prefilled SyringeSY6
858048paliperidone palmitate 78 MG per 0.5 ML Prefilled SyringeSY6

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
PALIPERIDONE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3752075e-d817-45ea-9aa1-8dc0301cf2aaProduct name120251114
893dce58-6330-4a9a-ab03-5ffd7148e184Product name120250311
b6847380-b533-d626-e29e-10b60b2ad451Product name920250303
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
fd328049-536a-4914-b42e-93bf4d93db24Product name120220307
0f0756fc-4d63-4f75-afcc-9c5e62a38d69Product name220220304
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63646-700-56Paliperidone Palmitate1 mL in 1 SYRINGEINJECTION, SUSPENSION, EXTENDED1 mL156 mg in 1mL6
63646-710-56Paliperidone Palmitate1 in 1 CARTONKIT16
63646-701-39Paliperidone Palmitate0.25 mL in 1 SYRINGEINJECTION, SUSPENSION, EXTENDED0.25 mL39 mg in 0.25mL6
63646-711-39Paliperidone Palmitate1 in 1 CARTONKIT16
63646-702-78Paliperidone Palmitate0.5 mL in 1 SYRINGEINJECTION, SUSPENSION, EXTENDED0.5 mL78 mg in 0.5mL6
63646-712-78Paliperidone Palmitate1 in 1 CARTONKIT16
63646-703-17Paliperidone Palmitate0.75 mL in 1 SYRINGEINJECTION, SUSPENSION, EXTENDED0.75 mL117 mg in 0.75mL6
63646-713-17Paliperidone Palmitate1 in 1 CARTONKIT16
63646-704-34Paliperidone Palmitate1.5 mL in 1 SYRINGEINJECTION, SUSPENSION, EXTENDED1.5 mL234 mg in 1.5mL6
63646-714-34Paliperidone Palmitate1 in 1 CARTONKIT16

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63646-71163646-711-39
63646-70163646-701-39
63646-71263646-712-78
63646-70263646-702-78
63646-71363646-713-17
63646-70363646-703-17
63646-71063646-710-56
63646-70063646-700-56
63646-71463646-714-34
63646-70463646-704-34

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 40 matching rows.

Name, UNII, Kind table
NameUNIIKind
PALIPERIDONE PALMITATER8P8USM8FRACTIB
POLYSORBATE 207T1F30V5YHIACT
POLYETHYLENE GLYCOL 40004R4HFI6D95IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FIACT
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM3980JIH2SWIACT
SODIUM HYDROXIDE55X04QC32IIACT
WATER059QF0KO0RIACT
PALIPERIDONE PALMITATER8P8USM8FRACTIB
POLYSORBATE 207T1F30V5YHIACT
POLYETHYLENE GLYCOL 40004R4HFI6D95IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FIACT
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM3980JIH2SWIACT
SODIUM HYDROXIDE55X04QC32IIACT
WATER059QF0KO0RIACT
PALIPERIDONE PALMITATER8P8USM8FRACTIB
POLYSORBATE 207T1F30V5YHIACT
POLYETHYLENE GLYCOL 40004R4HFI6D95IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FIACT
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM3980JIH2SWIACT
SODIUM HYDROXIDE55X04QC32IIACT
WATER059QF0KO0RIACT
PALIPERIDONE PALMITATER8P8USM8FRACTIB
POLYSORBATE 207T1F30V5YHIACT
POLYETHYLENE GLYCOL 40004R4HFI6D95IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FIACT
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM3980JIH2SWIACT
SODIUM HYDROXIDE55X04QC32IIACT
WATER059QF0KO0RIACT
PALIPERIDONE PALMITATER8P8USM8FRACTIB
POLYSORBATE 207T1F30V5YHIACT
POLYETHYLENE GLYCOL 40004R4HFI6D95IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FIACT
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM3980JIH2SWIACT
SODIUM HYDROXIDE55X04QC32IIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
3be5f388-af7d-4d61-86ec-26f743d6d1f5a08ab93b-0bac-42fd-8357-d10a49301b722026-03-23Exact identifier
spl id: 3be5f388-af7d-4d61-86ec-26f743d6d1f5
spl set id: a08ab93b-0bac-42fd-8357-d10a49301b72

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.