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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 213761

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NDA 213761 describes OXYCODONE HYDROCHLORIDE, which is a drug marketed by Ani Pharms, Avanthi Inc, Dr Reddys Labs Sa, Genus Lifesciences, Lannett Co Inc, Novel Labs Inc, Abhai Llc, Alkem Labs Ltd, Ascent Pharms Inc, Aurolife Pharma Llc, Chartwell Molecular, Hibrow Hlthcare, Hikma, Pharm Assoc, Pharmobedient, Quagen, Rhodes Pharms, Specgx Llc, Vistapharm Llc, Actavis Elizabeth, Alvogen, Amneal Pharms, Epic Pharma Llc, Nesher Pharms, Nuvo Pharm, Strides Pharma Intl, Sun Pharm Inds Inc, Ph Health, Barr Labs Inc, and Watson Labs, and is included in fifty-one NDAs. It is available from thirty-five suppliers. Additional details are available on the OXYCODONE HYDROCHLORIDE profile page.

The generic ingredient in OXYCODONE HYDROCHLORIDE is ibuprofen; oxycodone hydrochloride. There are sixty-four drug master file entries for this compound. Additional details are available on the ibuprofen; oxycodone hydrochloride profile page.

Summary for 213761

Tradename:	OXYCODONE HYDROCHLORIDE
Applicant:	Quagen
Ingredient:	oxycodone hydrochloride
Patents:	0

Pharmacology for NDA: 213761

Mechanism of Action	Full Opioid Agonists

Suppliers and Packaging for NDA: 213761

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
OXYCODONE HYDROCHLORIDE	oxycodone hydrochloride	SOLUTION;ORAL	213761	ANDA	QUAGEN PHARMACEUTICALS LLC	70752-136	70752-136-10	1 BOTTLE, PLASTIC in 1 CARTON (70752-136-10) / 100 mL in 1 BOTTLE, PLASTIC
OXYCODONE HYDROCHLORIDE	oxycodone hydrochloride	SOLUTION;ORAL	213761	ANDA	QUAGEN PHARMACEUTICALS LLC	70752-136	70752-136-14	1 BOTTLE, PLASTIC in 1 CARTON (70752-136-14) / 500 mL in 1 BOTTLE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	5MG/5ML
Approval Date:	Jun 2, 2021	TE:	AA	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	100MG/5ML
Approval Date:	Jun 2, 2021	TE:	AA	RLD:	No

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