United States · FDA National Drug Code directory
Naltrexone Hydrochloride
A source-listed medicine record.
Factual source checks only. This page is not a clinically reviewed monograph. Historical or discontinued records may be included; listing does not confirm approval, current availability or pharmacy stock.
Medicine identity
- Source reference
- 53401-023_57e8b771-91e9-16e4-e063-6294a90af86c
- Product NDC
- 53401-023
- Form
- TABLET, FILM COATED
- Composition / generic term
- Naltrexone Hydrochloride
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Marketing category
- ANDA
- Marketing start / end (source format)
- 20250815
- Source listing expiry
- 20271231
Source-listed ingredients
- NALTREXONE HYDROCHLORIDE — 50 mg/1
These values do not establish equivalence or a dose recommendation.
Packages
- 30 TABLET, FILM COATED in 1 BOTTLE (53401-023-30) · 53401-023-30
- 60 TABLET, FILM COATED in 1 BOTTLE (53401-023-53) · 53401-023-53
Source and coverage
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Snapshot retrieved: 2026-09-17. This is the acquisition date, not a medical review date.
Clinical information, images and comparisons appear only when separately reviewed for this record. Coverage may be incomplete. Ask a pharmacist or clinician about your treatment.
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