FDA Orange Book
Generic for Trileptal
Trileptal contains oxcarbazepine. 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 Trileptal is oxcarbazepine. 19 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Trileptal products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| suspension, oral | 300MG/5ML | Marketed (Rx) | AB | 12 | AB |
| tablet, oral | 150MG | Marketed (Rx) | AB | 10 | AB |
| tablet, oral | 300MG | Marketed (Rx) | AB | 10 | AB |
| tablet, oral | 600MG | Marketed (Rx) | AB | 10 | AB |
NDA 021285, 021014, 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 oxcarbazepine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| GLENMARK PHARMACEUTICALS LTD | 077802 | AB (A-rated, therapeutically equivalent) | October 9, 2007 | 150MG, 300MG, 600MG |
| SUN PHARMACEUTICAL INDUSTRIES LTD | 077794 | AB (A-rated, therapeutically equivalent) | October 9, 2007 | 150MG, 300MG, 600MG |
| TARO PHARMACEUTICAL INDUSTRIES LTD | 077801 | AB (A-rated, therapeutically equivalent) | November 15, 2007 | 150MG, 300MG, 600MG |
| ANI PHARMACEUTICALS INC | 078005 | AB (A-rated, therapeutically equivalent) | December 11, 2007 | 150MG, 300MG, 600MG |
| BRECKENRIDGE PHARMACEUTICAL INC | 078069 | AB (A-rated, therapeutically equivalent) | January 11, 2008 | 150MG, 300MG, 600MG |
| RUBICON RESEARCH LTD | 077747 | AB (A-rated, therapeutically equivalent) | April 9, 2008 | 150MG, 300MG, 600MG |
| SUN PHARMACEUTICAL INDUSTRIES LTD | 078734 | AB (A-rated, therapeutically equivalent) | June 26, 2009 | 300MG/5ML |
| AMNEAL PHARMACEUTICALS | 202961 | AB (A-rated, therapeutically equivalent) | September 17, 2012 | 300MG/5ML |
| CHARTWELL RX SCIENCES LLC | 212428 | AB (A-rated, therapeutically equivalent) | June 21, 2021 | 300MG/5ML |
| ANNORA PHARMA PRIVATE LTD | 215939 | AB (A-rated, therapeutically equivalent) | January 11, 2022 | 150MG, 300MG, 600MG |
| RUBICON RESEARCH LTD | 215726 | AB (A-rated, therapeutically equivalent) | August 30, 2022 | 300MG/5ML |
| BIONPHARMA INC | 209652 | AB (A-rated, therapeutically equivalent) | November 4, 2022 | 300MG/5ML |
| AUCTA PHARMACEUTICALS INC | 215332 | AB (A-rated, therapeutically equivalent) | November 30, 2022 | 300MG/5ML |
| ALKEM LABORATORIES LTD | 213183 | AB (A-rated, therapeutically equivalent) | March 18, 2023 | 300MG/5ML |
| HETERO LABS LTD UNIT III | 216749 | AB (A-rated, therapeutically equivalent) | October 20, 2023 | 300MG/5ML |
| PHARMAZONE | 217782 | AB (A-rated, therapeutically equivalent) | February 14, 2024 | 300MG/5ML |
| BIOCON PHARMA INC | 218278 | AB (A-rated, therapeutically equivalent) | March 1, 2024 | 300MG/5ML |
| RUBICON RESEARCH LTD | 207717 | AB (A-rated, therapeutically equivalent) | March 5, 2024 | 150MG, 300MG, 600MG |
| MACLEODS PHARMACEUTICALS LTD | 207300 | AB (A-rated, therapeutically equivalent) | July 11, 2025 | 300MG/5ML |
| EPIC PHARMA LLC | 219556 | AB (A-rated, therapeutically equivalent) | March 2, 2026 | 150MG, 300MG, 600MG |
| UMEDICA LABORATORIES PVT LTD | 218341 | AB (A-rated, therapeutically equivalent) | April 29, 2026 | 150MG, 300MG, 600MG |
| MSN LABORATORIES PRIVATE LTD | 209020 | AB (A-rated, therapeutically equivalent) | May 29, 2026 | 300MG/5ML |
Trileptal NDC codes
Questions
Is there a generic for Trileptal?
Yes. The generic name for Trileptal is oxcarbazepine. 19 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 Trileptal?
The active ingredient in Trileptal is oxcarbazepine, 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 Trileptal and Oxcarbazepine
- What is Trileptal used for?FDA label uses
- Is Trileptal a controlled substance?Federal schedule
- What is Oxcarbazepine used for?FDA label uses
- Is Oxcarbazepine a controlled substance?Federal schedule
- Generic for Oxtellar XRFDA Orange Book
- Anti-epileptic Agents listFDA drug class
- NDC 0078-0337Trileptal NDC record
- NDC 0078-0357Trileptal NDC record
- NDC 0078-0456Trileptal NDC record