NDC 53401-023 – Naltrexone Hydrochloride

Naltrexone Hydrochloride 50 mg/1 · Tablet, Film Coated · Oral

Human Prescription Drug

Product NDC53401-023

Product details

Brand name
Naltrexone Hydrochloride
Generic name
Naltrexone Hydrochloride
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Dosage form
Tablet, Film Coated
Route
Oral
Marketing category
ANDA · ANDA075274
Marketed since
August 15, 2025
Listing expires
December 31, 2027
Pharmacologic class
Opioid Antagonist

Active ingredients

Uses, dosage, side effects and warnings for Naltrexone Hydrochloride →

Package NDC codes (3)

Package NDCDescriptionSince
53401-023-3030 TABLET, FILM COATED in 1 BOTTLE (53401-023-30)Jul 28, 2026
53401-023-31600 TABLET, FILM COATED in 1 BOTTLE (53401-023-31)Sep 17, 2026
53401-023-5360 TABLET, FILM COATED in 1 BOTTLE (53401-023-53)Jul 28, 2026

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