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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 018053

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NDA 018053 describes BUPIVACAINE HYDROCHLORIDE, which is a drug marketed by Aspiro, Civica, Eugia Pharma, Hikma Pharms, Hospira, Meitheal, Onesource Specialty, Somerset, B Braun Medical, Baxter Hlthcare Corp, Huons, and Intl Medicated, and is included in thirty-four NDAs. It is available from twenty-one suppliers. Additional details are available on the BUPIVACAINE HYDROCHLORIDE profile page.

The generic ingredient in BUPIVACAINE HYDROCHLORIDE is bupivacaine hydrochloride; epinephrine bitartrate. There are twelve drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the bupivacaine hydrochloride; epinephrine bitartrate profile page.

Summary for 018053

Tradename:	BUPIVACAINE HYDROCHLORIDE
Applicant:	Hospira
Ingredient:	bupivacaine hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	0.5%
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	0.25%
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	0.75%
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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