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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 040330


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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-six 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 ActionFull 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:RXDosage:TABLET;ORALStrength325MG;2.5MG
Approval Date:Jun 25, 1999TE:AARLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength325MG;5MG
Approval Date:Jun 25, 1999TE:AARLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength325MG;7.5MG
Approval Date:Nov 23, 2001TE:AARLD:No

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