Details for New Drug Application (NDA): 005010

NDA 005010 describes DEMEROL, which is a drug marketed by Hospira and Quagen and is included in two NDAs. It is available from two suppliers. Additional details are available on the DEMEROL profile page.

The generic ingredient in DEMEROL 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 005010

Tradename:	DEMEROL
Applicant:	Quagen
Ingredient:	meperidine hydrochloride
Patents:	0

Pharmacology for NDA: 005010

Mechanism of Action

Full Opioid Agonists

Medical Subject Heading (MeSH) Categories for 005010

Adjuvants, Anesthesia

Analgesics, Opioid

Narcotics

Suppliers and Packaging for NDA: 005010

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DEMEROL	meperidine hydrochloride	INJECTABLE;INJECTION	005010	NDA	Validus Pharmaceuticals LLC	30698-335	30698-335-01	100 TABLET in 1 BOTTLE, PLASTIC (30698-335-01)
DEMEROL	meperidine hydrochloride	SYRUP;ORAL	005010	NDA	Validus Pharmaceuticals LLC	30698-335	30698-335-01	100 TABLET in 1 BOTTLE, PLASTIC (30698-335-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	50MG/ML
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	100MG/ML
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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