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Last Updated: December 17, 2025

Details for New Drug Application (NDA): 080455

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NDA 080455 describes MEPERIDINE HYDROCHLORIDE, which is a drug marketed by Abbott, Baxter Hlthcare, Igi Labs Inc, Intl Medication, Parke Davis, Watson Labs, West-ward Pharms Int, Hikma, Barr, Duramed Pharms Barr, Epic Pharma Llc, Genus, Specgx Llc, Strides Pharma Intl, Sun Pharm Inds Inc, Sun Pharm Industries, Wyeth Ayerst, Hospira, and Icu Medical Inc, and is included in forty-two NDAs. It is available from three suppliers. Additional details are available on the MEPERIDINE HYDROCHLORIDE profile page.

The generic ingredient in MEPERIDINE HYDROCHLORIDE is meperidine hydrochloride. There are six drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the meperidine hydrochloride profile page.

Summary for 080455

Tradename:	MEPERIDINE HYDROCHLORIDE
Applicant:	West-ward Pharms Int
Ingredient:	meperidine hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 080455

Adjuvants, Anesthesia
Analgesics, Opioid
Narcotics

Profile for product number 007

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	25MG/ML
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AP	RLD:	No

Profile for product number 008

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	50MG/ML
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AP	RLD:	No

Profile for product number 009

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	75MG/ML
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AP	RLD:	No

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