Details for New Drug Application (NDA): 040330

NDA 040330 describes PERCOCET, which is a drug marketed by Endo Operations and Vintage Pharms Llc and is included in three NDAs. It is available from two suppliers. Additional details are available on the PERCOCET profile page.

The generic ingredient in PERCOCET is acetaminophen; oxycodone hydrochloride. There are sixty-six drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the acetaminophen; oxycodone hydrochloride profile page.

Summary for 040330

Tradename:	PERCOCET
Applicant:	Endo Operations
Ingredient:	acetaminophen; oxycodone hydrochloride
Patents:	0

Pharmacology for NDA: 040330

Mechanism of Action

Full Opioid Agonists

Suppliers and Packaging for NDA: 040330

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PERCOCET	acetaminophen; oxycodone hydrochloride	TABLET;ORAL	040330	ANDA	ENDO USA, Inc.	60951-602	60951-602-70	100 TABLET in 1 BOTTLE (60951-602-70)
PERCOCET	acetaminophen; oxycodone hydrochloride	TABLET;ORAL	040330	ANDA	ENDO USA, Inc.	60951-602	60951-602-85	500 TABLET in 1 BOTTLE (60951-602-85)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	325MG;2.5MG
Approval Date:	Jun 25, 1999	TE:	AA	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	325MG;5MG
Approval Date:	Jun 25, 1999	TE:	AA	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	325MG;7.5MG
Approval Date:	Nov 23, 2001	TE:	AA	RLD:	No

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