FDA Orange Book
Generic for Felbatol
Felbatol contains felbamate. 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 Felbatol is felbamate. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Felbatol products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| suspension, oral | 600MG/5ML | Discontinued | None | 3 | AB |
| tablet, oral | 400MG | Marketed (Rx) | AB | 4 | AB |
| tablet, oral | 600MG | Marketed (Rx) | AB | 4 | AB |
NDA 020189, held by MYLAN SPECIALTY LP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic felbamate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| AMNEAL PHARMACEUTICALS | 201680 | AB (A-rated, therapeutically equivalent) | September 13, 2011 | 400MG, 600MG |
| AMNEAL PHARMACEUTICALS | 202385 | AB (A-rated, therapeutically equivalent) | December 16, 2011 | 600MG/5ML |
| ANI PHARMACEUTICALS INC | 202284 | AB (A-rated, therapeutically equivalent) | November 4, 2015 | 400MG, 600MG |
| TARO PHARMACEUTICAL INDUSTRIES LTD | 207093 | AB (A-rated, therapeutically equivalent) | April 20, 2017 | 400MG, 600MG |
| ZYDUS LIFESCIENCES LTD | 208970 | AB (A-rated, therapeutically equivalent) | May 30, 2017 | 400MG, 600MG |
| TARO PHARMACEUTICAL INDUSTRIES LTD | 206314 | AB (A-rated, therapeutically equivalent) | June 16, 2017 | 600MG/5ML |
| NOVITIUM PHARMA LLC | 211333 | AB (A-rated, therapeutically equivalent) | May 31, 2019 | 600MG/5ML |
Felbatol NDC codes
Questions
Is there a generic for Felbatol?
Yes. The generic name for Felbatol is felbamate. 5 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 Felbatol?
The active ingredient in Felbatol is felbamate, 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.