FDA Orange Book
Generic for Actigall
Actigall contains ursodiol. 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 Actigall is ursodiol. 10 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Actigall products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 150MG | Discontinued | None | 1 | None |
| capsule, oral | 300MG | Marketed (Rx) | AB | 10 | AB |
NDA 019594, held by TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic ursodiol
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| EPIC PHARMA LLC | 075517 | AB (A-rated, therapeutically equivalent) | March 14, 2000 | 300MG |
| LANNETT CO INC | 079082 | AB (A-rated, therapeutically equivalent) | December 15, 2008 | 300MG |
| ABHAI LLC | 210707 | AB (A-rated, therapeutically equivalent) | May 17, 2018 | 300MG |
| ADAPTIS PHARMA PRIVATE LTD | 212452 | AB (A-rated, therapeutically equivalent) | October 30, 2019 | 300MG |
| RISING PHARMACEUTICALS | 213200 | AB (A-rated, therapeutically equivalent) | February 12, 2020 | 300MG |
| CHARTWELL RX SCIENCES LLC | 213555 | AB (A-rated, therapeutically equivalent) | August 17, 2020 | 300MG |
| ZYDUS LIFESCIENCES GLOBAL FZE | 214295 | AB (A-rated, therapeutically equivalent) | October 16, 2020 | 300MG |
| PHARMAZONE | 214329 | AB (A-rated, therapeutically equivalent) | July 28, 2021 | 300MG |
| AUROBINDO PHARMA LTD | 214849 | AB (A-rated, therapeutically equivalent) | November 28, 2022 | 300MG |
| STRIDES PHARMA GLOBAL PTE LTD | 210344 | None (No TE code listed) | January 16, 2026 | 150MG, 300MG |
Actigall NDC codes
Questions
Is there a generic for Actigall?
Yes. The generic name for Actigall is ursodiol. 10 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 Actigall?
The active ingredient in Actigall is ursodiol, 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.