Active ingredient
Paliperidone
86 finished FDA listings contain Paliperidone as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- PALIPERIDONE, PALIPERIDONE PALMITATE
- Dosage forms
- Injection, Injection, Suspension, Extended Release, Tablet, Extended Release, Tablet, Film Coated, Extended Release
- Routes
- Intramuscular, Oral
- Manufacturers / labelers
- 21
- Strengths listed
- 1.5 mg/1 · 1092 mg/3.5ml · 117 mg/.75ml · 156 mg/ml · 1560 mg/5ml · 234 mg/1.5ml · 273 mg/.88ml · 3 mg/1 · 351 mg/2.25ml · 39 mg/.25ml · 410 mg/1.32ml · 546 mg/1.75ml · 6 mg/1 · 78 mg/.5ml · 819 mg/2.63ml · 9 mg/1
- Brand names in FDA listings
- Erzofri Extended-Release, Invega, Invega Hafyera, Invega Sustenna, Invega Trinza
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 679314
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 021999 | JANSSEN PHARMS | 2006-12-19 | 4 |
| NDA 022264 | JANSSEN PHARMS | 2009-07-31 | 5 |
| NDA 207946 | JANSSEN PHARMS | 2015-05-18 | 6 |
| ANDA 203802 | RK PHARMA | 2015-09-24 | 3 |
| ANDA 205618 | SUN PHARM | 2018-04-06 | 16 |
| ANDA 204452 | ADAPTIS | 2019-06-12 | 4 |
| ANDA 204707 | AMNEAL PHARMS | 2019-09-23 | 10 |
| ANDA 212807 | CSPC OUYI | 2020-10-29 | 4 |
| ANDA 216174 | ASCENT PHARMS INC | 2023-08-23 | 4 |
| ANDA 218514 | AJANTA PHARMA LTD | 2024-06-26 | 4 |
| NDA 216352 | LUYE INNOMIND PHARMA | 2024-07-26 | 6 |
| ANDA 218330 | ALEMBIC | 2024-09-26 | 8 |
| ANDA 218755 | PHARMAZONE | 2025-09-04 | 12 |
Official labeling on DailyMed
- PALIPERIDONE TABLET, EXTENDED RELEASE [ANI PHARMACEUTICALS, INC.] · version 8 · 2026-07-29
- PALIPERIDONE TABLET, EXTENDED RELEASE [AJANTA PHARMA USA INC.] · version 5 · 2026-06-15
- PALIPERIDONE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK] · version 100 · 2026-05-28
- PALIPERIDONE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK] · version 100 · 2026-05-28
- PALIPERIDONE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK] · version 100 · 2026-05-28
- PALIPERIDONE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK] · version 100 · 2026-05-28
- PALIPERIDONE TABLET, FILM COATED, EXTENDED RELEASE [MAJOR PHARMACEUTICALS] · version 8 · 2026-05-13
- PALIPERIDONE TABLET, EXTENDED RELEASE [WESTMINSTER PHARMACEUTICALS, LLC] · version 2 · 2026-05-04
- PALIPERIDONE TABLET, FILM COATED, EXTENDED RELEASE [NORTHSTAR RXLLC] · version 8 · 2026-04-30
- PALIPERIDONE TABLET, EXTENDED RELEASE [CAMBER PHARMACEUTICALS, INC] · version 2 · 2026-04-30
- PALIPERIDONE TABLET, FILM COATED, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES, INC.] · version 12 · 2026-04-09
- INVEGA (PALIPERIDONE) TABLET, EXTENDED RELEASE [JANSSEN PHARMACEUTICALS, INC.] · version 43 · 2026-03-20
Showing the 12 most recent of 29 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.