FDA Orange Book
Generic for Imodium
Imodium contains loperamide. 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 Imodium is loperamide. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 2 of the 3 Imodium products the Orange Book lists.
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Imodium products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 2MG | Discontinued | None | 8 | AB |
| capsule, oral | 2MG | Discontinued | None | 8 | AB |
| solution, oral | 1MG/5ML | Discontinued | None | 0 | None |
NDA 017690, 017694, 019037, held by JOHNSON AND JOHNSON CONSUMER INC MCNEIL CONSUMER HEALTHCARE DIV. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic loperamide
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| MYLAN PHARMACEUTICALS INC | 072741 | AB (A-rated, therapeutically equivalent) | September 18, 1991 | 2MG, 2MG |
| TEVA PHARMACEUTICALS USA INC | 073192 | AB (A-rated, therapeutically equivalent) | April 30, 1992 | 2MG, 2MG |
| EDENBRIDGE PHARMACEUTICALS LLC | 215001 | AB (A-rated, therapeutically equivalent) | October 6, 2021 | 2MG, 2MG |
| BIONPHARMA INC | 215579 | AB (A-rated, therapeutically equivalent) | October 22, 2021 | 2MG, 2MG |
| RUBICON RESEARCH LTD | 216876 | AB (A-rated, therapeutically equivalent) | January 26, 2023 | 2MG, 2MG |
| ZYDUS LIFESCIENCES LTD | 217471 | AB (A-rated, therapeutically equivalent) | March 23, 2023 | 2MG, 2MG |
| JUBILANT CADISTA PHARMACEUTICALS INC | 217840 | AB (A-rated, therapeutically equivalent) | July 5, 2023 | 2MG, 2MG |
| AUROBINDO PHARMA LTD | 218122 | AB (A-rated, therapeutically equivalent) | September 5, 2023 | 2MG, 2MG |
Questions
Is there a generic for Imodium?
Yes. The generic name for Imodium is loperamide. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 2 of the 3 Imodium products the Orange Book lists.
What is the generic name for Imodium?
The active ingredient in Imodium is loperamide, 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.