DrugDashboards

Naltrexone Hydrochloride

Naltrexone Hydrochloride · NALTREXONE HYDROCHLORIDE 50 mg/1 · Tablet, Film Coated · Oral · Aphena Pharma Solutions - Tennessee, LLC

NDC 53401-0008-31 · 600 TABLET, FILM COATED in 1 BOTTLE · ANDA · View full market →

The short version

21 companies supply this market — deep enough that no single failure threatens the supply. A shortage here was resolved within the past year — markets usually stay tight for a while after.

The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.

Medicare Part D

All Part D pricing →

Matched to CMS's representative package for this drug (NDC 00406-1170-03) — same generic, strength, and dosage form. CMS prices one NDC per drug concept, not every package.

ⓘ How this was built
Data sources
  • CMS quarterly Prescription Drug Plan Formulary & Pricing files (SPUF)
Method

Negotiated 30-day point-of-sale unit prices and formulary terms aggregated across every unsuppressed Part D and MA-PD plan for the quarter shown. Point of sale means gross of confidential rebates. CMS publishes one representative NDC per drug concept (RxCUI) rather than every package, so these figures come from CMS's representative package for the same drug — matched on generic name, strength, and dosage form. Estimated from MedPAC's program-wide rebate aggregates (June 2023: DIR = 29% of gross Part D spending; brand rebates ≈ 25–40% of gross, generics minimal). Actual rebates are confidential and vary widely by drug — this is a range, not a fact about this drug.

Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.

Plans pay at point of saleⓘ
$1.46per unit
middle half $0.9659–$2.11 · 5,496 plans · Apr 1, 2026
Est. net of rebatesⓘ
≈ $1.46
generic — rebates are minimal, so net ≈ gross
Coverage & restrictions
100%of plans cover it
tier 2 · prior auth 0% · step therapy 0% · qty limit 0%

*No drug-level rebate is public — the estimate applies MedPAC's program-wide brand rebate range to this drug's gross price. Tracked here for 6 quarters since 2024.

NADAC price per unit

No NADAC pricing on file for this NDC — NADAC covers drugs dispensed by retail community pharmacies.

Supply fragility

Not scored — fragility is computed for NADAC-priced NDCs.

90-day shortage risk (model v2)

0.2%chance of a new FDA shortage posting for naltrexone hydrochloride (oral solid) in the next 90 days

OAI inspection at a producing facility (24 months) · sole-source market

For scale: the typical drug’s chance is about 0.1% — this one is in ordinary territory.

Backtested statistical model over the whole market, not this package alone. Model details →

Where it's made

Establishments this product's FDA label declares, located via FDA registration data. How we built this →

Regulatory

Application
ANDA075274
TE code
AB
Approval date
May 26, 1999
Patents / exclusivity
None on file

Shortage history

  • Shortage ended — Naltrexone Hydrochloride, Tablet, 50 mg (NDC 0406-1170-01)Feb 29, 2024 → Feb 11, 2026
  • Shortage ended — Naltrexone Hydrochloride, Tablet, 50 mg (NDC 0406-1170-03)Feb 29, 2024 → Feb 11, 2026
  • Shortage ended — Naltrexone Hydrochloride, Tablet, 50 mg (NDC 16729-081-01)Feb 29, 2024 → Feb 11, 2026
  • Shortage ended — Naltrexone Hydrochloride, Tablet, 50 mg (NDC 16729-081-10)Feb 29, 2024 → Feb 11, 2026
  • Shortage ended — Naltrexone Hydrochloride, Tablet, 50 mg (NDC 47335-326-08)Feb 29, 2024 → Feb 11, 2026
  • Shortage ended — Naltrexone Hydrochloride, Tablet, 50 mg (NDC 47335-326-18)Feb 29, 2024 → Feb 11, 2026
  • Shortage ended — Naltrexone Hydrochloride, Tablet, 50 mg (NDC 47335-326-83)Feb 29, 2024 → Feb 11, 2026
  • Shortage ended — Naltrexone Hydrochloride, Tablet, 50 mg (NDC 47335-326-88)Feb 29, 2024 → Feb 11, 2026
  • Shortage ended — Naltrexone Hydrochloride, Tablet, 50 mg (NDC 51224-206-30)Feb 29, 2024 → Feb 11, 2026
  • Shortage ended — Naltrexone Hydrochloride, Tablet, 50 mg (NDC 51224-206-50)Feb 29, 2024 → Feb 11, 2026
  • Shortage ended — Naltrexone Hydrochloride, Tablet, 50 mg (NDC 62135-242-60)Feb 29, 2024 → Feb 11, 2026
  • Shortage ended — Naltrexone Hydrochloride, Tablet, 50 mg (NDC 64850-300-01)Feb 29, 2024 → Feb 11, 2026
  • Shortage ended — Naltrexone Hydrochloride, Tablet, 50 mg (NDC 64850-300-30)Feb 29, 2024 → Feb 11, 2026
  • Shortage ended — Naltrexone Hydrochloride, Tablet, 50 mg (NDC 68094-909-30)Feb 29, 2024 → Feb 11, 2026
  • Shortage ended — Naltrexone Hydrochloride, Tablet, 50 mg (NDC 68094-909-50)Feb 29, 2024 → Feb 11, 2026

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of Naltrexone Hydrochloride (Tablet, Film Coated)

LabelerStrengthFirst seenLast seen
Aphena Pharma Solutions - Tennessee, LLCNALTREXONE HYDROCHLORIDE 50 mg/1Jul 15, 2026Sep 3, 2026
Bryant Ranch PrepackNALTREXONE HYDROCHLORIDE 50 mg/1Jul 15, 2026Sep 3, 2026
Coupler LLCNALTREXONE HYDROCHLORIDE 50 mg/1Jul 15, 2026Sep 3, 2026
Remedyrepack Inc.NALTREXONE HYDROCHLORIDE 50 mg/1Jul 15, 2026Sep 3, 2026
Accord Healthcare, Inc.NALTREXONE HYDROCHLORIDE 50 mg/1Jul 15, 2026Sep 2, 2026
American Health PackagingNALTREXONE HYDROCHLORIDE 50 mg/1Jul 15, 2026Sep 2, 2026
AvKARENALTREXONE HYDROCHLORIDE 50 mg/1Jul 15, 2026Sep 2, 2026
Chartwell RX, LLCNALTREXONE HYDROCHLORIDE 50 mg/1Jul 15, 2026Sep 2, 2026
Elite Laboratories, Inc.NALTREXONE HYDROCHLORIDE 50 mg/1Jul 15, 2026Sep 2, 2026
Golden State Medical Supply, Inc.NALTREXONE HYDROCHLORIDE 50 mg/1Jul 15, 2026Sep 2, 2026
Heritage Pharmaceuticals Inc d/b/a Avet Pharmaceuticals IncNALTREXONE HYDROCHLORIDE 50 mg/1Jul 15, 2026Sep 2, 2026
Major PharmaceuticalsNALTREXONE HYDROCHLORIDE 50 mg/1Jul 15, 2026Sep 2, 2026
NCS HealthCare of KY, LLC dba Vangard LabsNALTREXONE HYDROCHLORIDE 50 mg/1Jul 15, 2026Sep 2, 2026
NuCare Pharmaceuticals Inc.NALTREXONE HYDROCHLORIDE 50 mg/1Jul 15, 2026Sep 2, 2026
Proficient Rx LPNALTREXONE HYDROCHLORIDE 50 mg/1Jul 15, 2026Sep 2, 2026
SpecGx LLCNALTREXONE HYDROCHLORIDE 50 mg/1Jul 15, 2026Sep 2, 2026
Sun Pharmaceutical Industries, Inc.NALTREXONE HYDROCHLORIDE 50 mg/1Jul 15, 2026Sep 2, 2026
TAGI Pharma Inc.NALTREXONE HYDROCHLORIDE 50 mg/1Jul 15, 2026Sep 2, 2026
A-S Medication SolutionsNALTREXONE HYDROCHLORIDE 50 mg/1Jul 15, 2026Aug 31, 2026
Redpharm DrugNALTREXONE HYDROCHLORIDE 50 mg/1Jul 25, 2026Aug 29, 2026
Precision Dose Inc.NALTREXONE HYDROCHLORIDE 50 mg/1Jul 15, 2026Aug 28, 2026

Roster from daily NDC Directory diffs — first/last seen dates start July 2026.

Cite this page

DrugDashboards, "Naltrexone Hydrochloride — NDC 53401-0008-31," retrieved September 3, 2026, https://drugdashboards.com/drug/53401000831.

Free to cite with attribution — see how the data is put together.