Paliperidone Tablet, Extended Release
Product Images NDC 31722-320

Product Visual Gallery

This gallery contains 18 technical images submitted to the FDA as part of the official labeling for Paliperidone (NDC 31722-320). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Camber Pharmaceuticals, Inc, these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

FDA Label Image

1.5 mg-30s (1.5 mg 30s)

The label for Paliperidone Extended-Release Tablets 1.5 mg by Camber Pharmaceuticals, Inc., indicating a 30 tablet package for oral use. The label includes dosage instructions emphasizing whole swallow without dividing or chewing, storage conditions, and manufacturing details.*

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3 mg-30s (3 mg 30s)

Label for Paliperidone Extended-Release Tablets 3 mg by Camber Pharmaceuticals, Inc. The label specifies the dosage form as extended-release tablets for oral use, with instructions to swallow whole without dividing, crushing, or chewing. It contains 30 tablets per package and includes storage and dispensing directions, along with manufacturer and labeler information.*

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6 mg-30s (6 mg 30s)

Label for Paliperidone Extended-Release Tablets 6 mg by Camber Pharmaceuticals, Inc. The label includes NDC 31722-319-30 and states that the package contains 30 tablets. Instructions note tablets should be swallowed whole and taken once daily. Storage conditions and manufacturer details are also displayed.*

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9 mg-30s (9 mg 30s)

Label for Paliperidone Extended-Release Tablets 9 mg by Camber Pharmaceuticals, Inc. The label indicates oral extended-release tablets with a package size of 30 tablets. Usage instructions advise swallowing whole without dividing, crushing, or chewing. Storage instructions and manufacturer details are included on the right side.*

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10 (Table10)

A data table presenting treatment-emergent extrapyramidal symptoms (EPS)-related adverse events in adolescent subjects from schizophrenia studies. The table shows percentages of patients experiencing various EPS-related events such as hyperkinesia, dystonia, tremor, parkinsonism, and dyskinesia, across placebo and different daily doses of paliperidone (1.5 mg, 3 mg, 6 mg, and 12 mg). Footnotes define specific symptom groups included within each category.*

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1a (Table1a)

A data table titled "Change in Fasting Glucose from Three Placebo-Controlled, 6-Week, Fixed-Dose Studies in Adult Subjects with Schizophrenia," showing mean changes in serum glucose levels from baseline and proportions of patients with shifts from normal to high serum glucose across placebo and various daily doses of Paliperidone (3 mg, 6 mg, 9 mg, 12 mg). Data includes sample sizes and glucose change values in mg/dL and percentages.*

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1 (Table1b)

A data table showing changes in fasting glucose levels from baseline in adolescent subjects (12-17 years old) with schizophrenia over a 6-week placebo-controlled study. The table compares placebo to varying daily doses of Paliperidone (1.5 mg, 3 mg, 6 mg, and 12 mg), listing mean changes in serum glucose (mg/dL) and the proportion of patients with serum glucose shifts from normal to high (<100 mg/dL to ≥126 mg/dL).*

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2a (Table2a)

A data table titled 'Change in Fasting Lipids from Three Placebo-Controlled, 6-Week, Fixed-Dose Studies in Adult Subjects with Schizophrenia' showing mean changes from baseline and proportions of patients with shifts in cholesterol, LDL, HDL, and triglycerides levels. It compares placebo and paliperidone doses of 3 mg/day, 6 mg/day, 9 mg/day, and 12 mg/day, with sample sizes and percent changes listed for each lipid parameter.*

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2 (Table2b)

A data table titled 'Change in Fasting Lipids from a Placebo-Controlled 6-Week Study in Adolescent Subjects (12-17 years of age) with Schizophrenia.' It compares lipid changes and proportions of patients with lipid shifts across placebo and paliperidone doses (1.5 mg/day, 3 mg/day, 6 mg/day, 12 mg/day). Metrics include cholesterol, LDL, HDL, and triglycerides, with mean changes from baseline and percentages of patients shifting from normal to abnormal lipid levels.*

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3a (Table3a)

A data table summarizing mean change in body weight (kg) and proportion of subjects with 7% or more weight gain from baseline across placebo and varying daily doses of paliperidone (3 mg, 6 mg, 9 mg, and 12 mg) in adult schizophrenia studies over six weeks.*

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3 (Table3b)

Data table showing mean change in body weight (kg) and the proportion of subjects with 7% or greater gain in body weight in a placebo-controlled 6-week study of adolescents (12-17 years) with schizophrenia. The table compares placebo and various daily doses of paliperidone (1.5 mg, 3 mg, 6 mg, 12 mg), detailing weight change from baseline and percentage of subjects with significant weight gain.*

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4 (Table4)

Table showing adverse reactions reported in 2% or more of paliperidone-treated adult subjects with schizophrenia in three short-term, fixed-dose, placebo-controlled clinical trials. It lists the percentage of patients experiencing various reactions by body system or organ class for placebo and paliperidone doses of 3 mg, 6 mg, 9 mg, and 12 mg once daily.*

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5 (Table5)

Table presenting adverse reactions reported in at least 2% of paliperidone-treated adolescent subjects with schizophrenia in a fixed-dose, placebo-controlled clinical trial. The table lists body system or organ class adverse events and corresponding percentages of patients experiencing each reaction across placebo and paliperidone doses of 1.5 mg, 3 mg, 6 mg, and 12 mg once daily.*

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6 (Table6)

A table presenting adverse drug reactions reported by 2% or more of paliperidone-treated adult subjects with schizoaffective disorder in placebo-controlled clinical trials. The table compares percentages of patients experiencing various side effects across different paliperidone dosing regimens and placebo groups, categorized by body system or organ class.*

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7 (Table7)

A data table presenting Treatment-Emergent Extrapyramidal Symptoms (EPS) in schizophrenia patients, showing percentages of patients experiencing Parkinsonism and Akathisia, along with use of anticholinergic medications. The data compares placebo to paliperidone at doses of 3 mg, 6 mg, 9 mg, and 12 mg once daily.*

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8 (Table8)

A data table titled 'Treatment-Emergent Extrapyramidal Symptoms (EPS)-Related Adverse Events by MedDRA Preferred Term – Schizophrenia Studies in Adults' comparing the percentage of patients experiencing EPS-related adverse events across placebo and varying doses of paliperidone (3 mg, 6 mg, 9 mg, 12 mg once daily). The table lists EPS groups such as dyskinesia, dystonia, hyperkinesia, parkinsonism, and tremor, with detailed subgroup definitions provided below the table.*

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9 (Table9)

A data table titled 'Treatment-Emergent Extrapyramidal Symptoms (EPS)-Related Adverse Events by MedDRA Preferred Term – Schizoaffective Disorder Studies in Adults.' It compares the percentage of patients experiencing various EPS-related adverse events, such as dyskinesia, dystonia, hyperkinesia, parkinsonism, and tremor, across placebo and different paliperidone dosing groups (3-6 mg, 9-12 mg once-daily fixed dose, and 3-12 mg once-daily flexible dose). Additional footnotes define symptoms included in each EPS group.*

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Struct (Struct)

Chemical structure of paliperidone, depicting its molecular composition with labeled atoms and bonds, including nitrogen, oxygen, fluorine, and carbon groups. The structure is clearly defined in the image. Paliperidone is the active ingredient in the drug PALIPERIDONE.*

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.