Generic for Cortef: Hydrocortisone

Yes. The generic name for Cortef is hydrocortisone. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 3 of the 5 Cortef products the Orange Book lists.

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Cortef products in the Orange Book

Cortef products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
injectable, injection	50MG/ML	Discontinued	None	0	None
suspension, oral	EQ 10MG BASE/5ML	Discontinued	None	0	None
tablet, oral	10MG	Marketed (Rx)	AB	6	AB
tablet, oral	20MG	Marketed (Rx)	AB	6	AB
tablet, oral	5MG	Marketed (Rx)	AB	6	AB

NDA 009864, 009900, 008697, held by PHARMACIA AND UPJOHN CO. 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 Cortef
Company	ANDA	TE code	Approved	Strengths
IMPAX LABORATORIES INC	040646	AB (A-rated, therapeutically equivalent)	March 30, 2007	10MG, 20MG, 5MG
STRIDES PHARMA GLOBAL PTE LTD	207029	AB (A-rated, therapeutically equivalent)	April 27, 2017	10MG, 20MG, 5MG
AUROBINDO PHARMA LTD	214649	AB (A-rated, therapeutically equivalent)	July 17, 2023	10MG, 20MG, 5MG
ADAPTIS PHARMA PRIVATE LTD	217160	AB (A-rated, therapeutically equivalent)	November 25, 2024	10MG, 20MG, 5MG
NOVITIUM PHARMA LLC	217881	AB (A-rated, therapeutically equivalent)	May 2, 2025	10MG, 20MG, 5MG
APPCO PHARMA LLC	220329	AB (A-rated, therapeutically equivalent)	February 25, 2026	10MG, 20MG, 5MG

Cortef NDC codes

Questions

Is there a generic for Cortef?

Yes. The generic name for Cortef is hydrocortisone. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 3 of the 5 Cortef products the Orange Book lists.

What is the generic name for Cortef?

The active ingredient in Cortef 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.

Generic for Cortef