Is there a generic for Dibucaine hydrochloride?

The FDA Orange Book does not currently list an approved generic (ANDA) for Dibucaine hydrochloride. It is available as 1 brand (NDA) application.

What is the reference-listed drug for Dibucaine hydrochloride?

HEAVY SOLUTION NUPERCAINE (NDA 006203, NOVARTIS) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Dibucaine hydrochloride are approved?

Dibucaine hydrochloride is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Dibucaine hydrochloride

Dibucaine hydrochloride is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:HEAVY SOLUTION NUPERCAINE · NDA 006203

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
HEAVY SOLUTION NUPERCAINE	NOVARTIS	NDA 006203	—	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.

Dibucaine hydrochloride — frequently asked questions

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

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

Book a Demo