Skip to content
LookupMeds

Active ingredient

Naltrexone

45 finished FDA listings contain Naltrexone as their only active ingredient; 1 combination products also contain it.

See all listingsCompare with another medication

FDA NDC Directory

Ingredient names as written by FDA
NALTREXONE, NALTREXONE HYDROCHLORIDE
Dosage forms
Tablet, Film Coated
Routes
Oral
Manufacturers / labelers
21
Strengths listed
50 mg/1

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 7243

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 075274ELITE LABS1999-05-2624
ANDA 076264SPECGX LLC2002-03-228
ANDA 091205ACCORD HLTHCARE2011-08-174
ANDA 090356SUN PHARM2012-02-247
ANDA 207905CHARTWELL2017-07-212

Official labeling on DailyMed

Showing the 12 most recent of 44 labels.

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