FDA Orange Book
Generic for Seroquel XR
Seroquel XR contains quetiapine. 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 Seroquel XR is quetiapine. 11 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Seroquel XR products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, extended release, oral | EQ 150MG BASE | Marketed (Rx) | AB | 11 | AB |
| tablet, extended release, oral | EQ 200MG BASE | Marketed (Rx) | AB | 11 | AB |
| tablet, extended release, oral | EQ 300MG BASE | Marketed (Rx) | AB | 10 | AB |
| tablet, extended release, oral | EQ 400MG BASE | Marketed (Rx) | AB | 10 | AB |
| tablet, extended release, oral | EQ 50MG BASE | Marketed (Rx) | AB | 9 | AB |
NDA 022047, held by CHEPLAPHARM ARZNEIMITTEL GMBH. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic quetiapine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ACCORD HEALTHCARE INC | 090681 | AB (A-rated, therapeutically equivalent) | May 9, 2017 | EQ 150MG BASE, EQ 200MG BASE, EQ 300MG BASE, EQ 400MG BASE |
| PLATINUM PHARMACEUTICALS | 202939 | AB (A-rated, therapeutically equivalent) | May 9, 2017 | EQ 150MG BASE, EQ 200MG BASE, EQ 300MG BASE, EQ 400MG BASE, EQ 50MG BASE |
| LUPIN LTD | 204203 | AB (A-rated, therapeutically equivalent) | May 17, 2017 | EQ 150MG BASE, EQ 200MG BASE, EQ 300MG BASE, EQ 400MG BASE, EQ 50MG BASE |
| AUROBINDO PHARMA LTD | 207655 | AB (A-rated, therapeutically equivalent) | November 29, 2017 | EQ 150MG BASE, EQ 200MG BASE, EQ 300MG BASE, EQ 400MG BASE, EQ 50MG BASE |
| MACLEODS PHARMACEUTICALS LTD | 204253 | AB (A-rated, therapeutically equivalent) | November 29, 2017 | EQ 150MG BASE, EQ 200MG BASE, EQ 300MG BASE, EQ 400MG BASE |
| NOVAST LABORATORIES LTD | 208947 | AB (A-rated, therapeutically equivalent) | November 29, 2017 | EQ 150MG BASE, EQ 200MG BASE, EQ 300MG BASE, EQ 400MG BASE, EQ 50MG BASE |
| SCIEGEN PHARMACEUTICALS INC | 209635 | AB (A-rated, therapeutically equivalent) | November 29, 2017 | EQ 150MG BASE, EQ 200MG BASE, EQ 300MG BASE, EQ 400MG BASE, EQ 50MG BASE |
| ACCORD HEALTHCARE INC | 206252 | AB (A-rated, therapeutically equivalent) | November 29, 2017 | EQ 50MG BASE |
| ALIGNSCIENCE PHARMA INC | 209497 | AB (A-rated, therapeutically equivalent) | September 28, 2018 | EQ 150MG BASE, EQ 200MG BASE |
| PRINSTON PHARMACEUTICAL INC | 208781 | AB (A-rated, therapeutically equivalent) | April 26, 2022 | EQ 150MG BASE, EQ 200MG BASE, EQ 300MG BASE, EQ 400MG BASE, EQ 50MG BASE |
| UNICHEM LABORATORIES LTD | 215478 | AB (A-rated, therapeutically equivalent) | August 15, 2022 | EQ 150MG BASE, EQ 200MG BASE, EQ 300MG BASE, EQ 400MG BASE, EQ 50MG BASE |
| RISING PHARMA HOLDINGS INC | 211144 | AB (A-rated, therapeutically equivalent) | November 26, 2024 | EQ 150MG BASE, EQ 200MG BASE, EQ 300MG BASE, EQ 400MG BASE, EQ 50MG BASE |
Seroquel XR NDC codes
Questions
Is there a generic for Seroquel XR?
Yes. The generic name for Seroquel XR is quetiapine. 11 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 Seroquel XR?
The active ingredient in Seroquel XR is quetiapine, 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.