FDA Orange Book
Generic for Tegretol
Tegretol 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 is carbamazepine. 10 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, BX.
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Tegretol products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| suspension, oral | 100MG/5ML | Marketed (Rx) | AB | 3 | AB |
| tablet, chewable, oral | 100MG | Discontinued | None | 3 | AB |
| tablet, oral | 200MG | Marketed (Rx) | AB | 7 | AB, BX |
NDA 018927, 018281, 016608, 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 |
|---|---|---|---|---|
| TEVA PHARMACEUTICALS USA INC | 073524 | AB (A-rated, therapeutically equivalent) | July 29, 1992 | 100MG |
| TARO PHARMACEUTICAL INDUSTRIES LTD | 074649 | AB (A-rated, therapeutically equivalent) | October 3, 1996 | 200MG |
| TARO PHARMACEUTICAL INDUSTRIES LTD | 075687 | AB (A-rated, therapeutically equivalent) | October 24, 2000 | 100MG |
| TORRENT PHARMACEUTICALS LTD | 075712 | AB (A-rated, therapeutically equivalent) | July 5, 2001 | 100MG |
| APOTEX INC | 075948 | AB (A-rated, therapeutically equivalent) | February 27, 2002 | 200MG |
| CHARTWELL RX SCIENCES LLC | 075714 | AB (A-rated, therapeutically equivalent) | June 5, 2002 | 100MG/5ML |
| TARO PHARMACEUTICAL INDUSTRIES LTD | 076729 | AB (A-rated, therapeutically equivalent) | September 20, 2004 | 100MG/5ML |
| TORRENT PHARMACEUTICALS LTD | 077272 | AB (A-rated, therapeutically equivalent) | December 7, 2005 | 200MG |
| UMEDICA LABORATORIES PRIVATE LTD | 207798 | BX (B-rated, not considered equivalent) | April 15, 2020 | 200MG |
| UNICHEM LABORATORIES LTD | 213284 | AB (A-rated, therapeutically equivalent) | August 22, 2022 | 200MG |
| NOVITIUM PHARMA LLC | 214277 | AB (A-rated, therapeutically equivalent) | October 6, 2022 | 100MG/5ML |
| BIONPHARMA INC | 218221 | AB (A-rated, therapeutically equivalent) | February 16, 2024 | 200MG |
| ALEMBIC PHARMACEUTICALS LTD | 216623 | AB (A-rated, therapeutically equivalent) | April 16, 2025 | 200MG |
Tegretol NDC codes
Questions
Is there a generic for Tegretol?
Yes. The generic name for Tegretol is carbamazepine. 10 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, BX.
What is the generic name for Tegretol?
The active ingredient in Tegretol 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.
More on Tegretol and Carbamazepine
- What is Tegretol used for?FDA label uses
- Is Tegretol a controlled substance?Federal schedule
- What is Carbamazepine used for?FDA label uses
- Is Carbamazepine a controlled substance?Federal schedule
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- NDC 0078-0508Tegretol NDC record
- NDC 0078-0509Tegretol NDC record
- NDC 0078-0510Tegretol NDC record