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Last Updated: December 31, 2025

Details for New Drug Application (NDA): 040778

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NDA 040778 describes OXYCODONE AND ACETAMINOPHEN, which is a drug marketed by Actavis Elizabeth, Barr, Duramed Pharms Barr, Halsey, Mallinckrodt, Mutual Pharm, Vintage Pharms, Vintage Pharms Llc, Watson Labs, Abhai Llc, Mikart, Sankalp Lifecare, Specgx Llc, Alvogen, Amneal Pharms, Amneal Pharms Ny, Ascent Pharms Inc, Aurolife Pharma Llc, Chartwell, Dr Reddys Labs Sa, Elite Labs Inc, Epic Pharma Llc, Granules, Lannett Co Inc, Nesher Pharms, Novel Labs Inc, Ph Health, Rhodes Pharms, Sanaluz, Sun Pharm Inds Inc, and Wes Pharma Inc, and is included in fifty-one NDAs. It is available from thirty-two suppliers. Additional details are available on the OXYCODONE AND ACETAMINOPHEN profile page.

The generic ingredient in OXYCODONE AND ACETAMINOPHEN 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 040778

Tradename:	OXYCODONE AND ACETAMINOPHEN
Applicant:	Amneal Pharms Ny
Ingredient:	acetaminophen; oxycodone hydrochloride
Patents:	0

Pharmacology for NDA: 040778

Mechanism of Action	Full Opioid Agonists

Suppliers and Packaging for NDA: 040778

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
OXYCODONE AND ACETAMINOPHEN	acetaminophen; oxycodone hydrochloride	TABLET;ORAL	040778	ANDA	AvPAK	50268-645	50268-645-15	50 BLISTER PACK in 1 BOX (50268-645-15) / 1 TABLET in 1 BLISTER PACK (50268-645-11)
OXYCODONE AND ACETAMINOPHEN	acetaminophen; oxycodone hydrochloride	TABLET;ORAL	040778	ANDA	AvPAK	50268-646	50268-646-15	50 BLISTER PACK in 1 BOX (50268-646-15) / 1 TABLET in 1 BLISTER PACK (50268-646-11)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	325MG;10MG
Approval Date:	Nov 27, 2007	TE:	AA	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	325MG;7.5MG
Approval Date:	Jun 27, 2014	TE:	AA	RLD:	No

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