FDA Orange Book
Generic for Tambocor
Tambocor contains flecainide acetate. 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 Tambocor is flecainide acetate. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 3 of the 4 Tambocor products the Orange Book lists.
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Tambocor products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 100MG | Discontinued | None | 8 | AB |
| tablet, oral | 150MG | Discontinued | None | 8 | AB |
| tablet, oral | 200MG | Discontinued | None | 0 | None |
| tablet, oral | 50MG | Discontinued | None | 8 | AB |
NDA 018830, held by ALVOGEN INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic flecainide acetate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| AMNEAL PHARMACEUTICAL | 075442 | AB (A-rated, therapeutically equivalent) | July 31, 2001 | 100MG, 150MG, 50MG |
| ANI PHARMACEUTICALS INC | 075882 | AB (A-rated, therapeutically equivalent) | October 28, 2002 | 100MG, 150MG, 50MG |
| HIKMA PHARMACEUTICALS USA INC | 076278 | AB (A-rated, therapeutically equivalent) | January 14, 2003 | 100MG, 150MG, 50MG |
| SUN PHARMACEUTICAL INDUSTRIES LTD | 076421 | AB (A-rated, therapeutically equivalent) | March 28, 2003 | 100MG, 150MG, 50MG |
| AUROBINDO PHARMA LTD | 202821 | AB (A-rated, therapeutically equivalent) | November 3, 2017 | 100MG, 150MG, 50MG |
| REGCON HOLDINGS LLC | 210683 | AB (A-rated, therapeutically equivalent) | September 16, 2020 | 100MG, 150MG, 50MG |
| YICHANG HUMANWELL PHARMACEUTICAL CO LTD | 215599 | AB (A-rated, therapeutically equivalent) | September 8, 2022 | 100MG, 150MG, 50MG |
| MICRO LABS LTD | 218093 | AB (A-rated, therapeutically equivalent) | April 22, 2026 | 100MG, 150MG, 50MG |
Questions
Is there a generic for Tambocor?
Yes. The generic name for Tambocor is flecainide acetate. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 3 of the 4 Tambocor products the Orange Book lists.
What is the generic name for Tambocor?
The active ingredient in Tambocor is flecainide acetate, 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.