DrugDashboards

Metaxalone

Metaxalone · METAXALONE 800 mg/1 · Tablet · Oral · Phoenix Rx Llc

NDC 85509-1435-09 · 90 TABLET in 1 BOTTLE · ANDA · View full market →

The short version

33 companies supply this market — deep enough that no single failure threatens the supply.

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 00527-1435-01) — 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
$1.73per unit
middle half $1.45$2.62 · 200 plans · Apr 1, 2026
Est. net of rebates
≈ $1.73
generic — rebates are minimal, so net ≈ gross
Coverage & restrictions
4%of plans cover it
tier 2 · prior auth 55% · step therapy 6% · qty limit 8%

*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 10 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)

0.1%chance of a new FDA shortage posting for metaxalone (oral solid) in the next 90 days

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
ANDA204770
TE code
AB
Approval date
Nov 22, 2016
Patents / exclusivity
None on file

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of Metaxalone (Tablet)

LabelerStrengthFirst seenLast seen
Advanced Rx of Tennessee, LLCMETAXALONE 800 mg/1Jul 15, 2026Sep 3, 2026
Advanced Rx Pharmacy of Tennessee, LLCMETAXALONE 800 mg/1Jul 15, 2026Sep 3, 2026
Bryant Ranch PrepackMETAXALONE 800 mg/1Jul 15, 2026Sep 3, 2026
Direct RxMETAXALONE 800 mg/1Jul 15, 2026Sep 3, 2026
Direct_RxMETAXALONE 800 mg/1Jul 15, 2026Sep 3, 2026
Phoenix Rx LlcMETAXALONE 800 mg/1Jul 15, 2026Sep 3, 2026
St. Mary's Medical Park PharmacyMETAXALONE 800 mg/1Jul 15, 2026Sep 3, 2026
Actavis Pharma, Inc.METAXALONE 800 mg/1Jul 15, 2026Sep 2, 2026
American Health PackagingMETAXALONE 800 mg/1Jul 15, 2026Sep 2, 2026
Amneal Pharmaceuticals LLCMETAXALONE 800 mg/1Jul 15, 2026Sep 2, 2026
Amneal Pharmaceuticals of New York LLCMETAXALONE 800 mg/1Jul 15, 2026Sep 2, 2026
Amneal Pharmaceuticals of New York LLCMETAXALONE 400 mg/1Jul 15, 2026Sep 2, 2026
AvPAKMETAXALONE 800 mg/1Jul 15, 2026Sep 2, 2026
BluePoint LaboratoriesMETAXALONE 800 mg/1Jul 15, 2026Sep 2, 2026
Cipla Usa Inc.METAXALONE 400 mg/1Jul 15, 2026Sep 2, 2026
Dr. Reddys Laboratories LimitedMETAXALONE 800 mg/1Jul 15, 2026Sep 2, 2026
Highmark Pharma LLCMETAXALONE 400 mg/1Jul 15, 2026Sep 2, 2026
INA Pharmaceutics IncMETAXALONE 640 mg/1Jul 15, 2026Sep 2, 2026
Lannett Company, Inc.METAXALONE 800 mg/1Jul 15, 2026Sep 2, 2026
Major PharmaceuticalsMETAXALONE 800 mg/1Jul 15, 2026Sep 2, 2026
Misemer Pharmaceuticals, Inc.METAXALONE 400 mg/1Jul 15, 2026Sep 2, 2026
Northwind Health Company, LLCMETAXALONE 800 mg/1Jul 15, 2026Sep 2, 2026
PD-Rx Pharmaceuticals, Inc.METAXALONE 800 mg/1Jul 15, 2026Sep 2, 2026
Preferred Pharmaceuticals, Inc.METAXALONE 800 mg/1Jul 15, 2026Sep 2, 2026
Quality Care Products, LLCMETAXALONE 800 mg/1Jul 15, 2026Sep 2, 2026
ScieGen Pharmaceuticals, Inc.METAXALONE 800 mg/1Jul 15, 2026Sep 2, 2026
ScieGen Pharmaceuticals, Inc.METAXALONE 400 mg/1Jul 15, 2026Sep 2, 2026
Asclemed USA, Inc.METAXALONE 800 mg/1Jul 15, 2026Aug 31, 2026
Preferred Pharmaceuticals Inc.METAXALONE 800 mg/1Jul 15, 2026Aug 31, 2026
Proficient Rx LPMETAXALONE 800 mg/1Jul 15, 2026Aug 31, 2026
A-S Medication SolutionsMETAXALONE 800 mg/1Jul 15, 2026Aug 28, 2026
AvKAREMETAXALONE 800 mg/1Jul 15, 2026Aug 28, 2026
Doc RxMETAXALONE 800 mg/1Jul 15, 2026Aug 28, 2026
Remedyrepack Inc.METAXALONE 800 mg/1Jul 15, 2026Aug 28, 2026
Sportpharm LLCMETAXALONE 800 mg/1Jul 15, 2026Aug 28, 2026

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

Cite this page

DrugDashboards, "Metaxalone — NDC 85509-1435-09," retrieved September 3, 2026, https://drugdashboards.com/drug/85509143509.

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