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Active ingredient

Oxymorphone

27 finished FDA listings contain Oxymorphone as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
OXYMORPHONE HYDROCHLORIDE
Dosage forms
Tablet, Tablet, Film Coated, Extended Release
Routes
Oral
Manufacturers / labelers
9
Strengths listed
10 mg/1 · 15 mg/1 · 20 mg/1 · 30 mg/1 · 40 mg/1 · 5 mg/1 · 7.5 mg/1

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 7814

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
ANDA 079087IMPAX LABS2010-06-1414
ANDA 090964HIKMA2010-09-272
ANDA 203601AVANTHI INC2013-01-302
ANDA 201187EPIC PHARMA LLC2014-12-152
ANDA 204459AUROLIFE PHARMA LLC2016-04-262
ANDA 210175ASCENT PHARMS INC2018-02-025

Official labeling on DailyMed

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.