FDA Orange Book
Generic for Imdur
Imdur contains isosorbide mononitrate. 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 Imdur is isosorbide mononitrate. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Imdur products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, extended release, oral | 120MG | Discontinued | None | 7 | AB |
| tablet, extended release, oral | 30MG | Discontinued | None | 7 | AB |
| tablet, extended release, oral | 60MG | Discontinued | None | 7 | AB |
NDA 020225, held by SCHERING PLOUGH CORP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic isosorbide mononitrate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ZYDUS HEALTHCARE USA LLC | 075395 | AB (A-rated, therapeutically equivalent) | March 16, 2000 | 120MG, 30MG, 60MG |
| CHARTWELL MOLECULAR HOLDINGS LLC | 075155 | AB (A-rated, therapeutically equivalent) | August 4, 2000 | 120MG, 30MG, 60MG |
| TORRENT PHARMACEUTICALS LTD | 200495 | AB (A-rated, therapeutically equivalent) | June 3, 2011 | 120MG, 60MG |
| TORRENT PHARMACEUTICALS LTD | 200270 | AB (A-rated, therapeutically equivalent) | June 3, 2011 | 30MG |
| DEXCEL LTD | 075522 | AB (A-rated, therapeutically equivalent) | September 20, 2016 | 30MG, 60MG |
| DEXCEL LTD | 210822 | AB (A-rated, therapeutically equivalent) | August 29, 2018 | 120MG |
| RICONPHARMA LLC | 210918 | AB (A-rated, therapeutically equivalent) | November 5, 2018 | 120MG, 30MG, 60MG |
| SHANDONG NEW TIME PHARMACEUTICAL CO LTD | 214115 | AB (A-rated, therapeutically equivalent) | April 29, 2022 | 120MG, 30MG, 60MG |
| AUROBINDO PHARMA LTD | 216557 | AB (A-rated, therapeutically equivalent) | November 7, 2022 | 120MG, 30MG, 60MG |
Questions
Is there a generic for Imdur?
Yes. The generic name for Imdur is isosorbide mononitrate. 7 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 Imdur?
The active ingredient in Imdur is isosorbide mononitrate, 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.