FDA Orange Book

Generic for Ketalar

Ketalar contains ketamine. 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 Ketalar is ketamine. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.

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Ketalar products in the Orange Book

Ketalar products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
injectable, injection	EQ 100MG BASE/ML	Marketed (Rx)	AP	5	AP
injectable, injection	EQ 10MG BASE/ML	Marketed (Rx)	AP	3	AP
injectable, injection	EQ 50MG BASE/ML	Marketed (Rx)	AP	5	AP

NDA 016812, held by PH HEALTH LTD. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic ketamine

Approved generic versions of Ketalar
Company	ANDA	TE code	Approved	Strengths
HIKMA PHARMACEUTICALS USA INC	074524	AP (A-rated, therapeutically equivalent)	March 22, 1996	EQ 100MG BASE/ML, EQ 50MG BASE/ML
HOSPIRA INC	074549	AP (A-rated, therapeutically equivalent)	June 27, 1996	EQ 100MG BASE/ML, EQ 50MG BASE/ML
EUGIA PHARMA SPECIALITIES LTD	076092	AP (A-rated, therapeutically equivalent)	October 25, 2002	EQ 100MG BASE/ML, EQ 10MG BASE/ML, EQ 50MG BASE/ML
GLAND PHARMA LTD	216809	AP (A-rated, therapeutically equivalent)	January 24, 2023	EQ 100MG BASE/ML, EQ 10MG BASE/ML, EQ 50MG BASE/ML
FRESENIUS KABI USA LLC	215808	AP (A-rated, therapeutically equivalent)	April 18, 2025	EQ 100MG BASE/ML, EQ 10MG BASE/ML, EQ 50MG BASE/ML

Ketalar NDC codes

Questions

Is there a generic for Ketalar?

Yes. The generic name for Ketalar is ketamine. 5 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 Ketalar?

The active ingredient in Ketalar is ketamine, 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.