FDA Orange Book
Generic for Inspra
Inspra contains eplerenone. 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 Inspra is eplerenone. 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 Inspra products the Orange Book lists.
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Inspra products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 100MG | Discontinued | None | 0 | None |
| tablet, oral | 25MG | Marketed (Rx) | AB | 8 | AB |
| tablet, oral | 50MG | Marketed (Rx) | AB | 8 | AB |
NDA 021437, held by UPJOHN US 2 LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic eplerenone
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| CHARTWELL RX SCIENCES LLC | 078482 | AB (A-rated, therapeutically equivalent) | July 30, 2008 | 25MG, 50MG |
| SANDOZ INC | 078510 | AB (A-rated, therapeutically equivalent) | August 1, 2008 | 25MG, 50MG |
| ACCORD HEALTHCARE INC | 206922 | AB (A-rated, therapeutically equivalent) | July 13, 2017 | 25MG, 50MG |
| BRECKENRIDGE PHARMACEUTICAL INC | 208283 | AB (A-rated, therapeutically equivalent) | September 14, 2018 | 25MG, 50MG |
| PHARMAZONE | 212765 | AB (A-rated, therapeutically equivalent) | August 10, 2020 | 25MG, 50MG |
| EVEREST LIFESCIENCES LLC | 207842 | AB (A-rated, therapeutically equivalent) | October 25, 2021 | 25MG, 50MG |
| RISING PHARMA HOLDINGS INC | 214663 | AB (A-rated, therapeutically equivalent) | March 23, 2022 | 25MG, 50MG |
| ANNORA PHARMA PRIVATE LTD | 213812 | AB (A-rated, therapeutically equivalent) | June 2, 2023 | 25MG, 50MG |
Inspra NDC codes
Questions
Is there a generic for Inspra?
Yes. The generic name for Inspra is eplerenone. 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 Inspra products the Orange Book lists.
What is the generic name for Inspra?
The active ingredient in Inspra is eplerenone, 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.