FDA Orange Book
Generic for Carospir
Carospir contains spironolactone. 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 Carospir is spironolactone. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Carospir products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| suspension, oral | 25MG/5ML | Marketed (Rx) | AB | 2 | AB |
NDA 209478, held by CMP DEVELOPMENT LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic spironolactone
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| AMNEAL PHARMACEUTICALS LLC | 215572 | AB (A-rated, therapeutically equivalent) | September 5, 2023 | 25MG/5ML |
| HETERO LABS LTD UNIT III | 218085 | AB (A-rated, therapeutically equivalent) | February 21, 2025 | 25MG/5ML |
Carospir patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9757394 | October 28, 2036 | Drug product | U-2109 | 209478 |
| 11395828 | October 28, 2036 | Method of use | U-2109 | 209478 |
| 11395828 | October 28, 2036 | Method of use | U-3401 | 209478 |
| 11395828 | October 28, 2036 | Method of use | U-3402 | 209478 |
| 10888570 | October 28, 2036 | Drug product | None | 209478 |
| 11389461 | October 28, 2036 | Drug product | None | 209478 |
| 10660907 | October 28, 2036 | Drug product | None | 209478 |
| 10624906 | October 28, 2036 | Drug product | None | 209478 |
| 10493083 | October 28, 2036 | Drug product | None | 209478 |
| 11491166 | October 28, 2036 | Drug product | None | 209478 |
Carospir NDC codes
Questions
Is there a generic for Carospir?
Yes. The generic name for Carospir is spironolactone. 2 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 Carospir?
The active ingredient in Carospir is spironolactone, per the FDA Orange Book.
When does the Carospir patent expire?
The last patent listed for Carospir in the Orange Book expires October 28, 2036. A listed patent expiry date is not a generic launch date.
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.