FDA Orange Book
Is there a generic for Khindivi?
Khindivi contains hydrocortisone. 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
No. The Orange Book lists no active FDA-approved generic (ANDA) for Khindivi (hydrocortisone). The Orange Book shows its last listed patent expires February 23, 2043.
Run it in Rivvi
Map Khindivi and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Khindivi products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, oral | 1MG/ML | Marketed (Rx) | None | 0 | None |
NDA 218980, held by ETON PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Khindivi patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 12133914 | February 23, 2043 | Method of use | U-4215 | 218980 |
| 11904046 | February 23, 2043 | Drug product | U-4216 | 218980 |
Khindivi NDC codes
Questions
Is there a generic for Khindivi?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Khindivi (hydrocortisone). The Orange Book shows its last listed patent expires February 23, 2043.
What is the generic name for Khindivi?
The active ingredient in Khindivi is hydrocortisone, per the FDA Orange Book.
When does the Khindivi patent expire?
The last patent listed for Khindivi in the Orange Book expires February 23, 2043. 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.
More on Khindivi and Hydrocortisone
- What is Hydrocortisone used for?FDA label uses
- Is Hydrocortisone a controlled substance?Federal schedule
- Generic for Cort-domeFDA Orange Book
- Generic for CortenemaFDA Orange Book
- Generic for Alkindi SprinkleFDA Orange Book
- Generic for CortefFDA Orange Book
- Generic for Solu-CortefFDA Orange Book
- Corticosteroids listFDA drug class
- NDC 71863-116Khindivi NDC record