FDA Orange Book
Generic for Sorbitrate
Sorbitrate 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 Sorbitrate 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 2 of the 6 Sorbitrate products the Orange Book lists.
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Sorbitrate products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, chewable, oral | 10MG | Discontinued | None | 0 | None |
| tablet, chewable, oral | 5MG | Discontinued | None | 0 | None |
| tablet, oral | 10MG | Discontinued | None | 5 | AB |
| tablet, oral | 5MG | Discontinued | None | 5 | AB |
| tablet, sublingual | 2.5MG | Discontinued | None | 0 | None |
| tablet, sublingual | 5MG | Discontinued | None | 0 | None |
NDA 016776, 016192, 016191, held by ASTRAZENECA PHARMACEUTICALS LP. 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 |
| HIKMA PHARMACEUTICALS USA INC | 088088 | AB (A-rated, therapeutically equivalent) | October 29, 1987 | 10MG, 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 |
| ZYDUS LIFESCIENCES GLOBAL FZE | 213057 | AB (A-rated, therapeutically equivalent) | November 20, 2019 | 10MG, 5MG |
| RUBICON RESEARCH LTD | 215723 | AB (A-rated, therapeutically equivalent) | July 8, 2022 | 10MG, 5MG |
Questions
Is there a generic for Sorbitrate?
Yes. The generic name for Sorbitrate 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 2 of the 6 Sorbitrate products the Orange Book lists.
What is the generic name for Sorbitrate?
The active ingredient in Sorbitrate 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.