Naltrexone

380MG/VIAL for suspension, extended releaseUnited StatesNot marketedAuthorised 6 Jul 2023

In other countries

The same active substances on other registers, the same brand first.

Two medicines in one question?

Name two or more medicines and Osler runs an interaction check. A severe interaction is stated at the very top of the answer.

Discover Osler

Naltrexone

380MG/VIAL for suspension, extended releaseUnited StatesNot marketedAuthorised 6 Jul 2023

Open in the registerAsk Osler about it

In other countries

The same active substances on other registers, the same brand first.

Two medicines in one question?

Name two or more medicines and Osler runs an interaction check. A severe interaction is stated at the very top of the answer.

Discover Osler

Tranalex 50 MG Comprimidos Recubiertos con Pelicula EfgSpain · 50 mg · comprimido recubierto con película · Accord Healthcare S.L.U.

Revia Comprimidos RecubiertosSpain · 50 mg · comprimido recubierto con película · Bristol-Myers Squibb

Adepend 50 mg filmom obložene tableteCroatia · filmom obložena tableta · Walter Ritter GmbH + Co. KG, Spaldingstraße 110B, Hamburg, Njemačka

Naltreksonklorid Walter Ritter 50 mg filmom obložene tableteCroatia · filmom obložena tableta · Walter Ritter GmbH + Co. KG, Spaldingstraße 110B, Hamburg, Njemačka

NalorexItaly · Compressa rivestita con film · L. Molteni & C. Dei F.Lli Alitti Societa' di Esercizio S.P.A.

Naltrexone Accord HealthcareItaly · Compressa rivestita con film · Accord Healthcare, S.L.U.

Naltrexon HCl Walter Ritter 50 mg filmomhulde tablettenNetherlands · Filmomhulde tablet · Walter Ritter GmbH & Co. KG

Naltrexon Hydrochloride Accord 50 mg filmomhulde tablettenNetherlands · Filmomhulde tablet · Accord Healthcare B.V.

Naltrexonhydrochloride 50 PCH, filmomhulde tabletten 50 mgNetherlands · Filmomhulde tablet · Pharmachemie B.V.

NaltraccordNew Zealand · Tab 50 mg

Naltrexone-GHNew Zealand · Tab 50 mg

NALTREXONA AMOMED 50 mgRomania · 50mg · compr. film. · Amomed Pharma GMBH

NALTREXONA TORREX 50 mgRomania · 50mg · compr. film. · Amomed Pharma GMBH

Naltrekson Abela PharmSerbia · 50mg · film tableta · Abela Pharm DOO Beograd

NARPAN TABLET 50 mgSingapore · 50 mg · tablet · Duopharma (Singapore) Pte LTD

Notholic 50mg Film-coated TabletsTaiwan · 膜衣錠 · 美時化學製藥股份有限公司

Packs

Pack	Code	Status
NALTREXONE 380MG/VIAL	ANDA213195-001	Discontinued

Documents

The official texts, at the regulator.

Register entryFDA

Sources and licences

Compiled by Prognia from the public register below; the register’s text is the official one.

U.S. Food and Drug Administration (Drugs@FDA) and openFDA drug labels

Source: U.S. Food and Drug Administration, Drugs@FDA and openFDA drug labels (imported 10 June 2026). Not endorsed by the FDA.

Licence: Public domain (U.S. Government work); openFDA terms · Added 10 Jun 2026

Report an error or request removalCorrections from the holder or the register are welcome.

Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.

At a glance

Active substance: Naltrexone
Strength: 380MG/VIAL
Dosage form: for suspension, extended release
Route: intramuscular
Register: United States (FDA)
Status: Not marketed
Status in the register: Discontinued
Authorised: 6 Jul 2023
Registration: ANDA 213195
Marketing authorisation holder: Teva Pharms USA INC
Procedure: ANDA (generic)

ReviaNaltrexone · 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tabletUnited States