Last Updated: November 9, 2026

Details for New Drug Application (NDA): 090964

« Back to Dashboard

NDA 090964 describes OXYMORPHONE HYDROCHLORIDE, which is a drug marketed by Actavis Elizabeth, Hikma, Impax Labs, Par Pharm, Specgx Llc, Sun Pharm Inds Ltd, Ascent Pharms Inc, Aurolife Pharma Llc, Avanthi Inc, Epic Pharma Llc, and Teva, and is included in thirteen NDAs. It is available from nine suppliers. Additional details are available on the OXYMORPHONE HYDROCHLORIDE profile page.

The generic ingredient in OXYMORPHONE HYDROCHLORIDE is oxymorphone hydrochloride. There is one drug master file entry for this compound. Nine suppliers are listed for this compound. Additional details are available on the oxymorphone hydrochloride profile page.

Summary for 090964

Tradename:	OXYMORPHONE HYDROCHLORIDE
Applicant:	Hikma
Ingredient:	oxymorphone hydrochloride
Patents:	0

Pharmacology for NDA: 090964

Mechanism of Action	Full Opioid Agonists

Medical Subject Heading (MeSH) Categories for 090964

Adjuvants, Anesthesia
Analgesics, Opioid
Narcotics

Suppliers and Packaging for NDA: 090964

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
OXYMORPHONE HYDROCHLORIDE	oxymorphone hydrochloride	TABLET;ORAL	090964	ANDA	Hikma Pharmaceuticals USA Inc.	0054-0283	0054-0283-25	100 TABLET in 1 BOTTLE (0054-0283-25)
OXYMORPHONE HYDROCHLORIDE	oxymorphone hydrochloride	TABLET;ORAL	090964	ANDA	Hikma Pharmaceuticals USA Inc.	0054-0284	0054-0284-25	100 TABLET in 1 BOTTLE (0054-0284-25)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Sep 27, 2010	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Sep 27, 2010	TE:	AB	RLD:	No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.