Is there a generic for Mebendazole?

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

What is the reference-listed drug for Mebendazole?

VERMOX (NDA 208398, JANSSEN PHARMS) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Mebendazole are approved?

Mebendazole is approved in the following dosage form: tablet, chewable.

FDA Orange Book · active-ingredient family

Mebendazole

Mebendazole is approved as 2 brand and 1 generic application in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:VERMOX · NDA 208398

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · tablet, chewable

Product	Applicant	Application	TE	Approved
VERMOXRLD	JANSSEN PHARMS	NDA 208398	—	Oct 19, 2016
VERMOXRLD	JANSSEN PHARMS	NDA 017481	—	Approved Prior to Jan 1, 1982

Generic (ANDA) products (1)

Product	Applicant	Application	TE	Approved
EMVERM	IMPAX LABS INC	ANDA 073580	—	Jan 04, 1995

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.

Mebendazole — frequently asked questions

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

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