FDA Orange Book

Generic for Cortenema

Cortenema 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 Cortenema is hydrocortisone. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

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Cortenema products in the Orange Book

Cortenema products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
enema, rectal	100MG/60ML	Marketed (Rx)	AB	1	AB

NDA 016199, held by ANI PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic hydrocortisone

Approved generic versions of Cortenema
Company	ANDA	TE code	Approved	Strengths
CHARTWELL LIFE MOLECULES LLC	075172	AB (A-rated, therapeutically equivalent)	December 3, 1999	100MG/60ML

Cortenema NDC codes

Questions

Is there a generic for Cortenema?

Yes. The generic name for Cortenema is hydrocortisone. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

What is the generic name for Cortenema?

The active ingredient in Cortenema 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.