FDA Orange Book
Generic for Risperdal
Risperdal contains risperidone. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Risperdal is risperidone. 20 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA, AB. Generics match 12 of the 13 Risperdal products the Orange Book lists.
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Risperdal products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, oral | 1MG/ML | Marketed (Rx) | AA | 6 | AA |
| tablet, orally disintegrating, oral | 0.5MG | Discontinued | None | 6 | AB |
| tablet, orally disintegrating, oral | 1MG | Discontinued | None | 5 | AB |
| tablet, orally disintegrating, oral | 2MG | Discontinued | None | 6 | AB |
| tablet, orally disintegrating, oral | 3MG | Discontinued | None | 5 | AB |
| tablet, orally disintegrating, oral | 4MG | Discontinued | None | 5 | AB |
| tablet, oral | 0.25MG | Marketed (Rx) | AB | 12 | AB |
| tablet, oral | 0.5MG | Marketed (Rx) | AB | 12 | AB |
| tablet, oral | 1MG | Marketed (Rx) | AB | 12 | AB |
| tablet, oral | 2MG | Marketed (Rx) | AB | 12 | AB |
| tablet, oral | 3MG | Marketed (Rx) | AB | 12 | AB |
| tablet, oral | 4MG | Marketed (Rx) | AB | 12 | AB |
| tablet, oral | 5MG | Discontinued | None | 0 | None |
NDA 020588, 021444, 020272, held by JANSSEN PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic risperidone
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| RISING PHARMA HOLDINGS INC | 078269 | AB (A-rated, therapeutically equivalent) | October 8, 2008 | 0.25MG, 0.5MG, 1MG, 2MG, 3MG, 4MG |
| NOVITIUM PHARMA LLC | 078871 | AB (A-rated, therapeutically equivalent) | October 9, 2008 | 0.25MG, 0.5MG, 1MG, 2MG, 3MG, 4MG |
| ZYDUS PHARMACEUTICALS USA INC | 078040 | AB (A-rated, therapeutically equivalent) | October 16, 2008 | 0.25MG, 0.5MG, 1MG, 2MG, 3MG, 4MG |
| DR REDDYS LABORATORIES LTD | 076879 | AB (A-rated, therapeutically equivalent) | October 24, 2008 | 0.25MG, 0.5MG, 1MG, 2MG, 3MG, 4MG |
| TORRENT PHARMACEUTICALS LTD | 079088 | AB (A-rated, therapeutically equivalent) | October 30, 2008 | 0.25MG, 0.5MG, 1MG, 2MG, 3MG, 4MG |
| RENATA PLC | 078707 | AB (A-rated, therapeutically equivalent) | December 29, 2008 | 0.25MG, 0.5MG, 1MG, 2MG, 3MG, 4MG |
| ANI PHARMACEUTICALS INC | 076440 | AA (A-rated, therapeutically equivalent) | January 30, 2009 | 1MG/ML |
| PHARMAZONE | 077328 | AB (A-rated, therapeutically equivalent) | February 24, 2009 | 0.5MG, 1MG, 2MG, 3MG, 4MG |
| JUBILANT CADISTA PHARMACEUTICALS INC | 078828 | AB (A-rated, therapeutically equivalent) | March 23, 2009 | 0.25MG, 0.5MG, 1MG, 2MG, 3MG, 4MG |
| PH HEALTH LTD | 077494 | AB (A-rated, therapeutically equivalent) | April 30, 2009 | 0.5MG, 1MG, 2MG, 3MG, 4MG |
| ZYDUS PHARMACEUTICALS USA INC | 078516 | AB (A-rated, therapeutically equivalent) | May 1, 2009 | 0.5MG, 2MG |
| PHARMAZONE | 078909 | AA (A-rated, therapeutically equivalent) | July 29, 2009 | 1MG/ML |
| AUROBINDO PHARMA LTD | 078452 | AA (A-rated, therapeutically equivalent) | September 4, 2009 | 1MG/ML |
| SANDOZ INC | 078528 | AB (A-rated, therapeutically equivalent) | October 16, 2009 | 0.25MG, 0.5MG, 1MG, 2MG, 3MG, 4MG |
| SANDOZ INC | 078116 | AB (A-rated, therapeutically equivalent) | December 22, 2009 | 0.5MG, 1MG, 2MG, 3MG, 4MG |
| SUN PHARMACEUTICAL INDUSTRIES LTD | 077542 | AB (A-rated, therapeutically equivalent) | August 6, 2010 | 0.5MG, 1MG, 2MG |
| SUN PHARMACEUTICAL INDUSTRIES LTD | 078474 | AB (A-rated, therapeutically equivalent) | August 6, 2010 | 3MG, 4MG |
| CHARTWELL MOLECULAR HOLDINGS LLC | 077543 | AB (A-rated, therapeutically equivalent) | May 18, 2011 | 0.25MG, 0.5MG, 1MG, 2MG, 3MG, 4MG |
| AMNEAL PHARMACEUTICALS | 091384 | AA (A-rated, therapeutically equivalent) | May 25, 2011 | 1MG/ML |
| AJANTA PHARMA LTD | 201003 | AB (A-rated, therapeutically equivalent) | August 24, 2011 | 0.25MG, 0.5MG, 1MG, 2MG, 3MG, 4MG |
| JUBILANT GENERICS LTD | 090839 | AB (A-rated, therapeutically equivalent) | November 4, 2011 | 0.5MG, 1MG, 2MG, 3MG, 4MG |
| PRINSTON PHARMACEUTICAL INC | 077493 | AB (A-rated, therapeutically equivalent) | November 29, 2011 | 0.25MG, 0.5MG, 1MG, 2MG, 3MG, 4MG |
| TRIS PHARMA INC | 079059 | AA (A-rated, therapeutically equivalent) | December 12, 2012 | 1MG/ML |
| CHARTWELL MOLECULAR HOLDINGS LLC | 202386 | AA (A-rated, therapeutically equivalent) | January 12, 2015 | 1MG/ML |
| IPCA LABORATORIES LTD | 205104 | AB (A-rated, therapeutically equivalent) | June 26, 2024 | 0.25MG, 0.5MG, 1MG, 2MG, 3MG, 4MG |
Risperdal NDC codes
Questions
Is there a generic for Risperdal?
Yes. The generic name for Risperdal is risperidone. 20 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA, AB. Generics match 12 of the 13 Risperdal products the Orange Book lists.
What is the generic name for Risperdal?
The active ingredient in Risperdal is risperidone, per the FDA Orange Book.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.
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