FDA Orange Book
Generic for Zonalon
Zonalon contains doxepin. 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 Zonalon is doxepin. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
Run it in Rivvi
Map Zonalon and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Zonalon products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| cream, topical | 5% | Marketed (Rx) | AB | 3 | AB |
NDA 020126, held by MYLAN PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic doxepin
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| TEVA PHARMACEUTICALS DEVELOPMENT INC | 215408 | AB (A-rated, therapeutically equivalent) | February 17, 2023 | 5% |
| AMNEAL PHARMACEUTICALS LLC | 212357 | AB (A-rated, therapeutically equivalent) | August 16, 2023 | 5% |
| SUN PHARMA CANADA INC | 213919 | AB (A-rated, therapeutically equivalent) | April 28, 2026 | 5% |
Zonalon NDC codes
Questions
Is there a generic for Zonalon?
Yes. The generic name for Zonalon is doxepin. 3 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 Zonalon?
The active ingredient in Zonalon is doxepin, 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.