FDA Orange Book
Generic for Risperdal Consta
Risperdal Consta 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 Consta is risperidone. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
Run it in Rivvi
Map Risperdal Consta and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Risperdal Consta products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| powder, intramuscular | 12.5MG/VIAL | Marketed (Rx) | AB | 2 | AB |
| powder, intramuscular | 25MG/VIAL | Marketed (Rx) | AB | 3 | AB |
| powder, intramuscular | 37.5MG/VIAL | Marketed (Rx) | AB | 3 | AB |
| powder, intramuscular | 50MG/VIAL | Marketed (Rx) | AB | 3 | AB |
NDA 021346, 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 |
|---|---|---|---|---|
| TEVA PHARMACEUTICALS USA INC | 214068 | AB (A-rated, therapeutically equivalent) | December 5, 2023 | 12.5MG/VIAL, 25MG/VIAL, 37.5MG/VIAL, 50MG/VIAL |
| AMNEAL EU LTD | 218586 | AB (A-rated, therapeutically equivalent) | September 2, 2025 | 12.5MG/VIAL, 25MG/VIAL, 37.5MG/VIAL, 50MG/VIAL |
| NANOMI BV | 211220 | AB (A-rated, therapeutically equivalent) | September 2, 2025 | 25MG/VIAL, 37.5MG/VIAL, 50MG/VIAL |
Questions
Is there a generic for Risperdal Consta?
Yes. The generic name for Risperdal Consta is risperidone. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Risperdal Consta?
The active ingredient in Risperdal Consta 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.