FDA Orange Book

Generic for Dilantin

Dilantin contains phenytoin. 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 Dilantin is phenytoin. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.

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Dilantin products in the Orange Book

Dilantin products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
injectable, injection	50MG/ML	Discontinued	None	2	AP

NDA 010151, held by PARKE DAVIS PHARMACEUTICAL RESEARCH DIV WARNER LAMBERT CO. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic phenytoin

Approved generic versions of Dilantin
Company	ANDA	TE code	Approved	Strengths
ACELLA PHARMACEUTICALS LLC	040573	AP (A-rated, therapeutically equivalent)	September 13, 2006	50MG/ML
HIKMA PHARMACEUTICALS USA INC	084307	AP (A-rated, therapeutically equivalent)	Approved Prior to Jan 1, 1982	50MG/ML

Questions

Is there a generic for Dilantin?

Yes. The generic name for Dilantin is phenytoin. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.

What is the generic name for Dilantin?

The active ingredient in Dilantin is phenytoin, 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.