FDA Orange Book
Generic for Isordil
Isordil contains isosorbide dinitrate. 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 Isordil is isosorbide dinitrate. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 5 of the 10 Isordil products the Orange Book lists.
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Isordil products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, extended release, oral | 40MG | Discontinued | None | 0 | None |
| tablet, extended release, oral | 40MG | Discontinued | None | 0 | None |
| tablet, oral | 10MG | Discontinued | None | 5 | AB |
| tablet, oral | 20MG | Discontinued | None | 5 | AB |
| tablet, oral | 30MG | Discontinued | None | 3 | AB |
| tablet, oral | 40MG | Marketed (Rx) | AB | 3 | AB |
| tablet, oral | 5MG | Marketed (Rx) | AB | 5 | AB |
| tablet, sublingual | 10MG | Discontinued | None | 0 | None |
| tablet, sublingual | 2.5MG | Discontinued | None | 0 | None |
| tablet, sublingual | 5MG | Discontinued | None | 0 | None |
NDA 012882, 012093, 012940, held by WYETH AYERST LABORATORIES. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic isosorbide dinitrate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| PH HEALTH LTD | 086925 | AB (A-rated, therapeutically equivalent) | March 12, 1987 | 10MG |
| PH HEALTH LTD | 086923 | AB (A-rated, therapeutically equivalent) | March 12, 1987 | 5MG |
| PH HEALTH LTD | 087537 | AB (A-rated, therapeutically equivalent) | October 2, 1987 | 20MG |
| HIKMA PHARMACEUTICALS USA INC | 088088 | AB (A-rated, therapeutically equivalent) | October 29, 1987 | 10MG, 20MG, 5MG |
| SANDOZ INC | 086223 | AB (A-rated, therapeutically equivalent) | January 7, 1988 | 10MG |
| SANDOZ INC | 086221 | AB (A-rated, therapeutically equivalent) | January 7, 1988 | 5MG |
| PH HEALTH LTD | 087946 | AB (A-rated, therapeutically equivalent) | January 12, 1988 | 30MG |
| SANDOZ INC | 089367 | AB (A-rated, therapeutically equivalent) | April 7, 1988 | 20MG |
| ZYDUS LIFESCIENCES GLOBAL FZE | 213057 | AB (A-rated, therapeutically equivalent) | November 20, 2019 | 10MG, 20MG, 30MG, 40MG, 5MG |
| PH HEALTH LTD | 211290 | AB (A-rated, therapeutically equivalent) | November 23, 2021 | 40MG |
| RUBICON RESEARCH LTD | 215723 | AB (A-rated, therapeutically equivalent) | July 8, 2022 | 10MG, 20MG, 30MG, 40MG, 5MG |
Isordil NDC codes
Questions
Is there a generic for Isordil?
Yes. The generic name for Isordil is isosorbide dinitrate. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 5 of the 10 Isordil products the Orange Book lists.
What is the generic name for Isordil?
The active ingredient in Isordil is isosorbide dinitrate, 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.