Active ingredient
Risperidone
182 finished FDA listings contain Risperidone as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- RISPERIDONE
- Dosage forms
- Injection, Suspension, Extended Release, Solution, Tablet, Tablet, Film Coated, Tablet, Orally Disintegrating
- Routes
- Oral, Subcutaneous
- Manufacturers / labelers
- 38
- Strengths listed
- .25 mg/1 · .5 mg/1 · 1 mg/1 · 1 mg/ml · 100 mg/.28ml · 125 mg/.35ml · 150 mg/.42ml · 2 mg/1 · 200 mg/.56ml · 250 mg/.7ml · 3 mg/1 · 4 mg/1 · 50 mg/.14ml · 75 mg/.21ml
- Brand names in FDA listings
- Risperdal, Risperdal M-Tab, Uzedy
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 35636
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 020272 | JANSSEN PHARMS | 1993-12-29 | 5 |
| NDA 020588 | JANSSEN PHARMS | 1996-06-10 | 3 |
| NDA 021444 | JANSSEN PHARMS | 2003-04-02 | 5 |
| ANDA 078040 | ZYDUS PHARMS USA INC | 2008-10-16 | 27 |
| ANDA 079088 | TORRENT PHARMS | 2008-10-30 | 7 |
| ANDA 078707 | RENATA | 2008-12-29 | 12 |
| ANDA 076440 | ANI PHARMS | 2009-01-30 | 1 |
| ANDA 077328 | SENORES PHARMS | 2009-02-24 | 10 |
| ANDA 078828 | JUBILANT CADISTA | 2009-03-23 | 12 |
| ANDA 077494 | PH HEALTH | 2009-04-30 | 6 |
| ANDA 078071 | AMNEAL | 2009-06-17 | 6 |
| ANDA 078909 | APOZEAL PHARMS | 2009-07-29 | 1 |
| ANDA 078452 | AUROBINDO PHARMA LTD | 2009-09-04 | 1 |
| ANDA 077542 | SUN PHARM INDS LTD | 2010-08-06 | 3 |
| ANDA 078474 | SUN PHARM INDS LTD | 2010-08-06 | 2 |
| ANDA 091537 | NATCO PHARMA USA | 2011-03-30 | 6 |
| ANDA 077543 | CHARTWELL MOLECULAR | 2011-05-18 | 6 |
| ANDA 091384 | AMNEAL PHARMS | 2011-05-25 | 1 |
| ANDA 201003 | AJANTA PHARMA LTD | 2011-08-24 | 32 |
| ANDA 090839 | JUBILANT GENERICS | 2011-11-04 | 5 |
| ANDA 077493 | PRINSTON INC | 2011-11-29 | 18 |
| ANDA 079059 | TRIS PHARMA INC | 2012-12-12 | 5 |
| ANDA 202386 | CHARTWELL MOLECULAR | 2015-01-12 | 1 |
| NDA 213586 | TEVA | 2023-04-28 | 7 |
Official labeling on DailyMed
- RISPERIDONE SOLUTION [APOZEAL PHARMACEUTICALS INC] · version 3 · 2026-09-01
- RISPERIDONE TABLET RISPERIDONE SOLUTION RISPERIDONE M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JANSSEN PHARMACEUTICALS, INC.] · version 35 · 2026-08-24
- RISPERIDONE TABLET, ORALLY DISINTEGRATING [PAR HEALTH USA, LLC] · version 33 · 2026-08-20
- RISPERDAL (RISPERIDONE) TABLET RISPERDAL M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING RISPERDAL (RISPERIDONE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.] · version 45 · 2026-08-20
- RISPERIDONE TABLET, ORALLY DISINTEGRATING [AMERISYN LLC] · version 1 · 2026-08-17
- RISPERIDONE TABLET [COUPLER LLC] · version 1 · 2026-08-06
- RISPERIDONE TABLET [COUPLER LLC] · version 2 · 2026-07-15
- RISPERIDONE SOLUTION [ATLANTIC BIOLOGICALS CORP.] · version 5 · 2026-07-13
- RISPERIDONE TABLET [REMEDYREPACK INC.] · version 19 · 2026-07-08
- RISPERIDONE TABLET [COUPLER LLC] · version 1 · 2026-07-07
- RISPERIDONE SOLUTION [ANI PHARMACEUTICALS, INC.] · version 3 · 2026-06-29
- RISPERIDONE TABLET [REMEDYREPACK INC.] · version 25 · 2026-06-26
Showing the 12 most recent of 66 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.