FDA Orange Book
Generic for Cort-dome
Cort-dome 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
Yes. The generic name for Cort-dome is hydrocortisone. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AT. Generics match 1 of the 4 Cort-dome products the Orange Book lists.
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Cort-dome products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| cream, topical | 0.5% | Discontinued | None | 0 | None |
| cream, topical | 1% | Discontinued | None | 3 | AT |
| lotion, topical | 0.5% | Discontinued | None | 0 | None |
| lotion, topical | 1% | Discontinued | None | 0 | None |
NDA 009585, 009895, held by BAYER PHARMACEUTICALS CORP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic hydrocortisone
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ACTAVIS MID ATLANTIC LLC | 087795 | AT (A-rated, therapeutically equivalent) | May 3, 1983 | 1% |
| CROWN LABORATORIES INC | 080706 | AT (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | 1% |
| FOUGERA PHARMACEUTICALS INC | 080693 | AT (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | 1% |
Questions
Is there a generic for Cort-dome?
Yes. The generic name for Cort-dome is hydrocortisone. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AT. Generics match 1 of the 4 Cort-dome products the Orange Book lists.
What is the generic name for Cort-dome?
The active ingredient in Cort-dome is hydrocortisone, 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.