FDA Orange Book
Generic for Tegretol-xr
Tegretol-xr contains carbamazepine. 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 Tegretol-xr is carbamazepine. 13 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Tegretol-xr products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, extended release, oral | 100MG | Marketed (Rx) | AB | 13 | AB |
| tablet, extended release, oral | 200MG | Marketed (Rx) | AB | 13 | AB |
| tablet, extended release, oral | 400MG | Marketed (Rx) | AB | 13 | AB |
NDA 020234, held by NOVARTIS PHARMACEUTICALS CORP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic carbamazepine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| TARO PHARMACEUTICAL INDUSTRIES LTD | 078115 | AB (A-rated, therapeutically equivalent) | March 31, 2009 | 100MG, 200MG, 400MG |
| ZYDUS PHARMACEUTICALS USA INC | 205571 | AB (A-rated, therapeutically equivalent) | February 7, 2019 | 100MG, 200MG, 400MG |
| UNIQUE PHARMACEUTICAL LABORATORIES | 211623 | AB (A-rated, therapeutically equivalent) | April 24, 2020 | 100MG, 200MG, 400MG |
| CSPC OUYI PHARMACEUTICAL CO LTD | 213311 | AB (A-rated, therapeutically equivalent) | April 13, 2021 | 100MG, 200MG, 400MG |
| ANBISON LABORATORY CO LTD | 212948 | AB (A-rated, therapeutically equivalent) | September 30, 2021 | 100MG, 200MG, 400MG |
| ZHEJIANG JIUZHOU BIOPHARMA CO LTD | 215591 | AB (A-rated, therapeutically equivalent) | March 31, 2022 | 100MG, 200MG, 400MG |
| UMEDICA LABORATORIES PRIVATE LTD | 216594 | AB (A-rated, therapeutically equivalent) | August 18, 2022 | 100MG, 200MG, 400MG |
| INGENUS PHARMACEUTICALS LLC | 216404 | AB (A-rated, therapeutically equivalent) | December 2, 2022 | 100MG, 200MG, 400MG |
| SCIECURE PHARMA INC | 216235 | AB (A-rated, therapeutically equivalent) | March 2, 2023 | 100MG, 200MG, 400MG |
| TORRENT PHARMACEUTICALS LTD | 212524 | AB (A-rated, therapeutically equivalent) | January 13, 2025 | 100MG, 200MG, 400MG |
| ALKEM LABORATORIES LTD | 217277 | AB (A-rated, therapeutically equivalent) | January 14, 2025 | 100MG, 200MG, 400MG |
| YICHANG HUMANWELL PHARMACEUTICAL CO LTD | 219072 | AB (A-rated, therapeutically equivalent) | January 16, 2025 | 100MG, 200MG, 400MG |
| ALEMBIC PHARMACEUTICALS LTD | 219939 | AB (A-rated, therapeutically equivalent) | July 25, 2025 | 100MG, 200MG, 400MG |
Tegretol-xr NDC codes
Questions
Is there a generic for Tegretol-xr?
Yes. The generic name for Tegretol-xr is carbamazepine. 13 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 Tegretol-xr?
The active ingredient in Tegretol-xr is carbamazepine, 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.