FDA Orange Book

Generic for Naprelan

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

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Naprelan products in the Orange Book

Naprelan products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
tablet, extended release, oral	EQ 375MG BASE	Marketed (Rx)	AB	1	AB
tablet, extended release, oral	EQ 500MG BASE	Marketed (Rx)	AB	1	AB
tablet, extended release, oral	EQ 750MG BASE	Marketed (Rx)	AB	1	AB

NDA 020353, held by TWI PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic naproxen

Approved generic versions of Naprelan
Company	ANDA	TE code	Approved	Strengths
ACTAVIS LABORATORIES FL INC	075416	AB (A-rated, therapeutically equivalent)	April 23, 2003	EQ 375MG BASE, EQ 500MG BASE, EQ 750MG BASE

Naprelan NDC codes

Questions

Is there a generic for Naprelan?

Yes. The generic name for Naprelan is naproxen. 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 Naprelan?

The active ingredient in Naprelan is naproxen, 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.