Is there a generic for Ibuprofen sodium?

Yes. The FDA Orange Book lists 1 approved generic (ANDA) application for Ibuprofen sodium, referencing the brand ADVIL. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Ibuprofen sodium?

ADVIL (NDA 201803, HALEON US HOLDINGS) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Ibuprofen sodium are approved?

Ibuprofen sodium is approved in the following dosage form: tablet.

FDA Orange Book · active-ingredient family

Ibuprofen sodium

Ibuprofen sodium is approved as 1 brand and 1 generic application in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:ADVIL · NDA 201803

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · tablet

Product	Applicant	Application	TE	Approved
ADVILRLD	HALEON US HOLDINGS	NDA 201803	—	Jun 12, 2012

Generic (ANDA) products (1)

Product	Applicant	Application	TE	Approved
IBUPROFEN SODIUM	PERRIGO R AND D	ANDA 206581	—	Aug 03, 2015

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.

Ibuprofen sodium — frequently asked questions

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

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