Quick answers
- What is Paliperidone used for?
- The FDA-approved label (Invega, Janssen Pharmaceuticals, Inc., January 31, 2025) says: “INVEGA is an atypical antipsychotic agent indicated for Treatment of schizophrenia Adults: Efficacy was established in three 6-week trials and one maintenance trial. Adolescents (ages 12–17): Efficacy was established in one 6-week trial. Treatment of schizoaffective disorder as monotherapy and as an adjunct to mood stabilizers and/or antidepressants. Efficacy was established in two 6-week trials in adult patients. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Paliperidone have a boxed warning?
- Yes. The FDA label for Invega has a boxed warning (“WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Paliperidone?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Paliperidone been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started February 28, 2022 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Paliperidone?
- 19 companies list prescription products of Paliperidone in the FDA NDC Directory, including NorthStar RxLLC, Camber Pharmaceuticals, Inc. and AvKARE.
What Paliperidone is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
INVEGA is an atypical antipsychotic agent indicated for Treatment of schizophrenia Adults: Efficacy was established in three 6-week trials and one maintenance trial. Adolescents (ages 12–17): Efficacy was established in one 6-week trial. Treatment of schizoaffective disorder as monotherapy and as an adjunct to mood stabilizers and/or antidepressants. Efficacy was established in two 6-week trials in adult patients. …
— FDA label: Invega, Janssen Pharmaceuticals, Inc., effective January 31, 2025. Read the full label on DailyMed →
The FDA has 25 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Its heading: WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS
. Read it on the full label →
25 of 25 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, extended release · Tablet, film coated, extended release |
|---|---|
| Route | Oral |
| Prescription products | 69 in the FDA NDC Directory |
| Brand names | Invega |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| paliperidone 1.5 mg tablet, extended release | Generic | $0.9177 per tablet |
| paliperidone 1.5 mg tablet, film coated, extended release | Generic | $0.9177 per tablet |
| paliperidone 3 mg tablet, extended release | Generic | $1.01 per tablet |
| paliperidone 3 mg tablet, extended release | Brand: Invega | $12.45 per tablet |
| paliperidone 3 mg tablet, film coated, extended release | Generic | $1.01 per tablet |
| paliperidone 6 mg tablet, extended release | Generic | $0.9788 per tablet |
| paliperidone 6 mg tablet, extended release | Brand: Invega | $12.35 per tablet |
| paliperidone 6 mg tablet, film coated, extended release | Generic | $0.9788 per tablet |
| paliperidone 9 mg tablet, extended release | Generic | $1.05 per tablet |
| paliperidone 9 mg tablet, extended release | Brand: Invega | $18.64 per tablet |
| paliperidone 9 mg tablet, film coated, extended release | Generic | $1.05 per tablet |
NADAC list of November 4, 2026; these prices took effect between January 2, 2026 and October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- NorthStar RxLLC4 products
- Camber Pharmaceuticals, Inc.4 products
- AvKARE4 products
- Sun Pharmaceutical Industries, Inc.4 products
- Alembic Pharmaceuticals Inc.4 products
- Amneal Pharmaceuticals LLC4 products
- Bryant Ranch Prepack4 products
- Eskayef Pharmaceuticals Limited4 products
- Alembic Pharmaceuticals Limited4 products
- Janssen Pharmaceuticals, Inc.4 products
- Westminster Pharmaceuticals, LLC4 products
- Ajanta Pharma USA Inc.4 products
- ANI Pharmaceuticals, Inc.4 products
- Tris Pharma Inc4 products
- Major Pharmaceuticals3 products
- Archis Pharma LLC3 products
- Remedyrepack Inc.3 products
- Coupler LLC2 products
- American Health Packaging2 products
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA021999 INVEGA | Janssen Pharms | December 19, 2006 | 29, latest January 23, 2025 2025: Labeling · 2025: Labeling · 2022: Manufacturing (CMC) |
Generic approvals (9)
- ANDA203802Rk Pharma · September 24, 2015
- ANDA205618Sun Pharm · April 6, 2018
- ANDA204452Adaptis · June 12, 2019
- ANDA204707Amneal Pharms · September 23, 2019
- ANDA212807Cspc Ouyi · October 29, 2020
- ANDA216174Ascent Pharms Inc · August 23, 2023
- ANDA218514Ajanta Pharma Ltd · June 26, 2024
- ANDA218330Alembic · September 26, 2024
- ANDA218755Pharmazone · September 4, 2025
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
February 28, 2022 · Class II · Terminated · D-0649-2022
Failed Dissolution Specifications
PALIPERIDONE EXTENDED-RELEASE TABLETS, 9 mg, 100 Tablets per carton (10 x 10 blister packs), Rx only, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15, Dadra-396 191, India. Distributed by: MAJOR PH — The Harvard Drug Group
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Invega, Janssen Pharmaceuticals, Inc., effective January 31, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →