FDA Orange Book

Generic for Demerol

Demerol contains meperidine. 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 Demerol is meperidine. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA, AP.

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Demerol products in the Orange Book

Demerol products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
injectable, injection	100MG/ML	Marketed (Rx)	AP	2	AP
injectable, injection	100MG/ML	Discontinued	None	2	AP
injectable, injection	25MG/ML	Marketed (Rx)	AP	2	AP
injectable, injection	25MG/ML	Discontinued	None	2	AP
injectable, injection	50MG/ML	Marketed (Rx)	AP	2	AP
injectable, injection	50MG/ML	Discontinued	None	2	AP
injectable, injection	75MG/ML	Marketed (Rx)	AP	2	AP
injectable, injection	75MG/ML	Discontinued	None	2	AP
syrup, oral	50MG/5ML	Discontinued	None	1	None
tablet, oral	100MG	Discontinued	None	1	None
tablet, oral	50MG	Discontinued	None	2	AA

NDA 021171, 005010, held by HOSPIRA INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic meperidine

Approved generic versions of Demerol
Company	ANDA	TE code	Approved	Strengths
HIKMA PHARMACEUTICALS USA INC	088744	None (No TE code listed)	January 30, 1985	50MG/5ML
EPIC PHARMA LLC	040331	None (No TE code listed)	May 28, 1999	100MG, 50MG
GENUS LIFESCIENCES INC	040893	AA (A-rated, therapeutically equivalent)	June 24, 2009	50MG
WEST-WARD PHARMACEUTICALS INTERNATIONAL LTD	080445	AP (A-rated, therapeutically equivalent)	Approved Prior to Jan 1, 1982	100MG/ML, 100MG/ML, 25MG/ML, 25MG/ML, 50MG/ML, 50MG/ML, 75MG/ML, 75MG/ML
WEST-WARD PHARMACEUTICALS INTERNATIONAL LTD	080455	AP (A-rated, therapeutically equivalent)	Approved Prior to Jan 1, 1982	100MG/ML, 100MG/ML, 25MG/ML, 25MG/ML, 50MG/ML, 50MG/ML, 75MG/ML, 75MG/ML

Demerol NDC codes

Questions

Is there a generic for Demerol?

Yes. The generic name for Demerol is meperidine. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA, AP.

What is the generic name for Demerol?

The active ingredient in Demerol is meperidine, 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.