Is there a generic for Naproxen?

Yes. The FDA Orange Book lists 37 approved generic (ANDA) applications for Naproxen, referencing the brand EC-NAPROSYN. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Naproxen?

EC-NAPROSYN (NDA 020067, ATNAHS PHARMA US) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Naproxen are approved?

Naproxen is approved in the following dosage forms: suspension, tablet, tablet, delayed release.

FDA Orange Book · active-ingredient family

Naproxen

Naproxen: 3 brands, 37 generics; first approved Apr 15, 1982; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available — 37 ANDA applications approved.

Brands (NDA)

Generics (ANDA)

Listed patents

Presentations

Originator applications

Brand (NDA) products

EC-NAPROSYNRLDRS

ATNAHS PHARMA USNDA 02006719942 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
375MG	TABLET, DELAYED RELEASE	ORAL	Rx	AB
500MG	TABLET, DELAYED RELEASE	ORAL	Rx	AB

NAPROSYNRLD

ATNAHS PHARMA USNDA 0189651987

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG/ML	SUSPENSION	ORAL	Rx	AB

NAPROSYNRLD

ATNAHS PHARMA USNDA 017581—3 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG	TABLET	ORAL	Discontinued	—
375MG	TABLET	ORAL	Discontinued	—
500MG	TABLET	ORAL	Rx	AB

Abbreviated applications

Generic (ANDA) products (37)

NAPROXEN

AUROBINDO PHARMAANDA 2165042025

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG/ML	SUSPENSION	ORAL	Discontinued	—

NAPROXEN

NOVITIUM PHARMAANDA 21849720242 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
375MG	TABLET, DELAYED RELEASE	ORAL	Rx	AB
500MG	TABLET, DELAYED RELEASE	ORAL	Rx	AB

NAPROXEN

TP ANDA HOLDINGSANDA 21690820232 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
375MG	TABLET, DELAYED RELEASE	ORAL	Rx	AB
500MG	TABLET, DELAYED RELEASE	ORAL	Rx	AB

NAPROXEN

HETERO LABS LTD IIIANDA 2157762022

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG/ML	SUSPENSION	ORAL	Rx	AB

NAPROXEN

NOVITIUM PHARMAANDA 2119102021

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG/ML	SUSPENSION	ORAL	Rx	AB

NAPROXEN

AMNEALANDA 2127052020

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG/ML	SUSPENSION	ORAL	Rx	AB

NAPROXEN

SCIEGEN PHARMSANDA 21251720203 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG	TABLET	ORAL	Rx	AB
375MG	TABLET	ORAL	Rx	AB
500MG	TABLET	ORAL	Rx	AB

NAPROXEN

AUROBINDO PHARMAANDA 20042920113 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG	TABLET	ORAL	Rx	AB
375MG	TABLET	ORAL	Rx	AB
500MG	TABLET	ORAL	Rx	AB

NAPROXEN

NUVO PHARMS INCANDA 09143220112 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
375MG	TABLET, DELAYED RELEASE	ORAL	Rx	AB
500MG	TABLET, DELAYED RELEASE	ORAL	Rx	AB

NAPROXEN

INVAGEN PHARMSANDA 09130520113 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG	TABLET	ORAL	Discontinued	—
375MG	TABLET	ORAL	Discontinued	—
500MG	TABLET	ORAL	Discontinued	—

NAPROXEN

ADAPTISANDA 09141620113 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG	TABLET	ORAL	Rx	AB
375MG	TABLET	ORAL	Rx	AB
500MG	TABLET	ORAL	Rx	AB

NAPROXEN

ZYDUS PHARMS USAANDA 07862020073 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG	TABLET	ORAL	Rx	AB
375MG	TABLET	ORAL	Rx	AB
500MG	TABLET	ORAL	Rx	AB

NAPROXEN

GLENMARK PHARMS LTDANDA 07825020073 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG	TABLET	ORAL	Rx	AB
375MG	TABLET	ORAL	Rx	AB
500MG	TABLET	ORAL	Rx	AB

NAPROXEN

L PERRIGO COANDA 07733920053 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG	TABLET	ORAL	Discontinued	—
375MG	TABLET	ORAL	Discontinued	—
500MG	TABLET	ORAL	Discontinued	—

NAPROXEN

HIKMA INTL PHARMSANDA 07649420043 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG	TABLET	ORAL	Discontinued	—
375MG	TABLET	ORAL	Discontinued	—
500MG	TABLET	ORAL	Discontinued	—

NAPROXEN

AMNEAL PHARMS NYANDA 07592720013 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG	TABLET	ORAL	Rx	AB
375MG	TABLET	ORAL	Rx	AB
500MG	TABLET	ORAL	Rx	AB

NAPROXEN

AUROBINDO PHARMA USAANDA 07539020012 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
375MG	TABLET, DELAYED RELEASE	ORAL	Rx	AB
500MG	TABLET, DELAYED RELEASE	ORAL	Rx	AB

NAPROXEN

PLIVAANDA 07533719992 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
375MG	TABLET, DELAYED RELEASE	ORAL	Discontinued	—
500MG	TABLET, DELAYED RELEASE	ORAL	Discontinued	—

NAPROXEN

TEVAANDA 07522719982 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
375MG	TABLET, DELAYED RELEASE	ORAL	Rx	AB
500MG	TABLET, DELAYED RELEASE	ORAL	Rx	AB

NAPROXEN

ACTAVIS ELIZABETHANDA 07493619982 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
375MG	TABLET, DELAYED RELEASE	ORAL	Discontinued	—
500MG	TABLET, DELAYED RELEASE	ORAL	Discontinued	—

NAPROXEN

FOSUN PHARMAANDA 07506119982 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
375MG	TABLET, DELAYED RELEASE	ORAL	Discontinued	—
500MG	TABLET, DELAYED RELEASE	ORAL	Discontinued	—

NAPROXEN

PLIVAANDA 07418219963 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG	TABLET	ORAL	Discontinued	—
375MG	TABLET	ORAL	Discontinued	—
500MG	TABLET	ORAL	Discontinued	—

NAPROXEN

TEVAANDA 07421619963 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG	TABLET	ORAL	Discontinued	—
375MG	TABLET	ORAL	Discontinued	—
500MG	TABLET	ORAL	Discontinued	—

NAPROXEN

WATSON LABSANDA 07445719953 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG	TABLET	ORAL	Discontinued	—
375MG	TABLET	ORAL	Discontinued	—
500MG	TABLET	ORAL	Discontinued	—

NAPROXEN

CHARTWELL MOLECULESANDA 07441019953 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG	TABLET	ORAL	Discontinued	—
375MG	TABLET	ORAL	Discontinued	—
500MG	TABLET	ORAL	Discontinued	—

NAPROXEN

IVAX SUB TEVA PHARMSANDA 07411119953 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG	TABLET	ORAL	Discontinued	—
375MG	TABLET	ORAL	Discontinued	—
500MG	TABLET	ORAL	Discontinued	—

NAPROXEN

WATSON LABS TEVAANDA 07416319953 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG	TABLET	ORAL	Discontinued	—
375MG	TABLET	ORAL	Discontinued	—
500MG	TABLET	ORAL	Discontinued	—

NAPROXENRS

HIKMAANDA 0741901994

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG/ML	SUSPENSION	ORAL	Rx	AB

NAPROXEN

ROXANEANDA 07421119943 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG	TABLET	ORAL	Discontinued	—
375MG	TABLET	ORAL	Discontinued	—
500MG	TABLET	ORAL	Discontinued	—

NAPROXEN

DAVA PHARMS INCANDA 07410519933 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG	TABLET	ORAL	Discontinued	—
375MG	TABLET	ORAL	Discontinued	—
500MG	TABLET	ORAL	Discontinued	—

NAPROXEN

GRANULESANDA 07414019933 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG	TABLET	ORAL	Rx	AB
375MG	TABLET	ORAL	Rx	AB
500MG	TABLET	ORAL	Rx	AB

NAPROXEN

PHARMOBEDIENTANDA 07412119933 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG	TABLET	ORAL	Discontinued	—
375MG	TABLET	ORAL	Discontinued	—
500MG	TABLET	ORAL	Discontinued	—

NAPROXEN

PUREPAC PHARMANDA 07426319933 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG	TABLET	ORAL	Discontinued	—
375MG	TABLET	ORAL	Discontinued	—
500MG	TABLET	ORAL	Discontinued	—

NAPROXEN

TEVAANDA 07412919933 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG	TABLET	ORAL	Discontinued	—
375MG	TABLET	ORAL	Discontinued	—
500MG	TABLET	ORAL	Discontinued	—

NAPROXEN

TEVAANDA 07420119933 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG	TABLET	ORAL	Rx	AB
375MG	TABLET	ORAL	Rx	AB
500MG	TABLET	ORAL	Rx	AB

NAPROXEN

TEVA PHARMSANDA 07420719933 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG	TABLET	ORAL	Discontinued	—
375MG	TABLET	ORAL	Discontinued	—
500MG	TABLET	ORAL	Discontinued	—

NAPROXEN

HAMILTON PHARMSANDA 07411019923 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG	TABLET	ORAL	Discontinued	—
375MG	TABLET	ORAL	Discontinued	—
500MG	TABLET	ORAL	Discontinued	—

Orange Book patent file

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

FDA approval span

Approval history

First approval

Apr 15, 1982

44 yr 11 mo ago

Most recent approval

Oct 03, 2025

9 mo ago

Approvals span 1982–2025 across 40 FDA applications.

Brand (NDA) 38%

Generic (ANDA) 3793%

Naproxen — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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