FDA Orange Book
Generic for Diclegis
Diclegis contains doxylamine and pyridoxine. 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 Diclegis is doxylamine and pyridoxine. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Diclegis products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, delayed release, oral | 10MG;10MG | Marketed (Rx) | AB | 3 | AB |
NDA 021876, held by DUCHESNAY INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic doxylamine and pyridoxine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ACTAVIS LABORATORIES FL INC | 205811 | AB (A-rated, therapeutically equivalent) | August 19, 2016 | 10MG;10MG |
| PH HEALTH LTD | 208518 | AB (A-rated, therapeutically equivalent) | December 6, 2017 | 10MG;10MG |
| BIONPHARMA INC | 217000 | AB (A-rated, therapeutically equivalent) | August 4, 2023 | 10MG;10MG |
Diclegis NDC codes
Questions
Is there a generic for Diclegis?
Yes. The generic name for Diclegis is doxylamine and pyridoxine. 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 Diclegis?
The active ingredient in Diclegis is doxylamine and pyridoxine, 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.