FDA Orange Book
Generic for Tessalon
Tessalon contains benzonatate. 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 Tessalon is benzonatate. 9 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA.
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Tessalon products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 100MG | Marketed (Rx) | AA | 9 | AA |
| capsule, oral | 200MG | Discontinued | None | 9 | AA |
NDA 011210, held by PFIZER INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic benzonatate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| BIONPHARMA INC | 081297 | AA (A-rated, therapeutically equivalent) | January 29, 1993 | 100MG, 200MG |
| THEPHARMANETWORK LLC | 040627 | AA (A-rated, therapeutically equivalent) | March 30, 2007 | 100MG, 200MG |
| ZYDUS PHARMACEUTICALS USA INC | 040597 | AA (A-rated, therapeutically equivalent) | June 8, 2007 | 100MG, 200MG |
| HERITAGE PHARMACEUTICALS LABS INC DBA AVET PHARMACEUTICALS LABS INC | 040682 | AA (A-rated, therapeutically equivalent) | July 30, 2007 | 100MG, 200MG |
| ONESOURCE SPECIALTY PTE LTD | 091133 | AA (A-rated, therapeutically equivalent) | July 30, 2015 | 100MG, 200MG |
| CSPC-NBP PHARMACEUTICAL CO LTD | 202765 | AA (A-rated, therapeutically equivalent) | August 25, 2017 | 100MG, 200MG |
| PURACAP PHARMACEUTICAL LLC | 206948 | AA (A-rated, therapeutically equivalent) | December 19, 2018 | 100MG, 200MG |
| ASCENT PHARMACEUTICALS INC | 211518 | AA (A-rated, therapeutically equivalent) | February 22, 2019 | 100MG, 200MG |
| PHARMAZONE | 220298 | AA (A-rated, therapeutically equivalent) | March 30, 2026 | 100MG, 200MG |
Questions
Is there a generic for Tessalon?
Yes. The generic name for Tessalon is benzonatate. 9 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA.
What is the generic name for Tessalon?
The active ingredient in Tessalon is benzonatate, 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.