Is there a generic for Methdilazine hydrochloride?

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

What is the reference-listed drug for Methdilazine hydrochloride?

TACARYL (NDA 011950, WESTWOOD SQUIBB) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Methdilazine hydrochloride are approved?

Methdilazine hydrochloride is approved in the following dosage forms: syrup, tablet.

FDA Orange Book · active-ingredient family

Methdilazine hydrochloride

Methdilazine hydrochloride 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:TACARYL · NDA 011950

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · syrup, tablet

Product	Applicant	Application	TE	Approved
TACARYL×2	WESTWOOD SQUIBB	NDA 011950	—	Approved Prior to Jan 1, 1982

Generic (ANDA) products (1)

Product	Applicant	Application	TE	Approved
METHDILAZINE HYDROCHLORIDE	ALPHARMA US PHARMS	ANDA 087122	—	Approved Prior to Jan 1, 1982

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.

Methdilazine hydrochloride — frequently asked questions

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

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