FDA Orange Book
Generic for Hydrocortone
Hydrocortone contains hydrocortisone acetate. 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 Hydrocortone is hydrocortisone acetate. 6 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 Hydrocortone products the Orange Book lists.
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Hydrocortone products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 25MG/ML | Discontinued | None | 0 | None |
| injectable, injection | 50MG/ML | Discontinued | None | 0 | None |
| injectable, injection | EQ 50MG BASE/ML | Discontinued | None | 0 | None |
| ointment, ophthalmic, otic | 1.5% | Discontinued | None | 0 | None |
| tablet, oral | 10MG | Discontinued | None | 6 | AB |
| tablet, oral | 20MG | Discontinued | None | 6 | AB |
NDA 008228, 012052, 009018, 008506, held by MERCK AND CO INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic hydrocortisone acetate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| IMPAX LABORATORIES INC | 040646 | AB (A-rated, therapeutically equivalent) | March 30, 2007 | 10MG, 20MG |
| STRIDES PHARMA GLOBAL PTE LTD | 207029 | AB (A-rated, therapeutically equivalent) | April 27, 2017 | 10MG, 20MG |
| AUROBINDO PHARMA LTD | 214649 | AB (A-rated, therapeutically equivalent) | July 17, 2023 | 10MG, 20MG |
| ADAPTIS PHARMA PRIVATE LTD | 217160 | AB (A-rated, therapeutically equivalent) | November 25, 2024 | 10MG, 20MG |
| NOVITIUM PHARMA LLC | 217881 | AB (A-rated, therapeutically equivalent) | May 2, 2025 | 10MG, 20MG |
| APPCO PHARMA LLC | 220329 | AB (A-rated, therapeutically equivalent) | February 25, 2026 | 10MG, 20MG |
Questions
Is there a generic for Hydrocortone?
Yes. The generic name for Hydrocortone is hydrocortisone acetate. 6 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 Hydrocortone products the Orange Book lists.
What is the generic name for Hydrocortone?
The active ingredient in Hydrocortone is hydrocortisone acetate, 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.