DrugDashboards

Mexiletine Hydrochloride

mexiletine hydrochloride · MEXILETINE HYDROCHLORIDE 250 mg/1 · Capsule · Oral · Amerisyn LLC

NDC 87564-0054-10 · 100 CAPSULE in 1 BOTTLE · ANDA · View full market →

The short version

14 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 00093-8741-01) — 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
$1.06per unit
middle half $0.6822$1.65 · 2,954 plans · Apr 1, 2026
Est. net of rebates
≈ $1.06
generic — rebates are minimal, so net ≈ gross
Coverage & restrictions
54%of plans cover it
tier 3 · 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 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 mexiletine hydrochloride (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 →

Regulatory

Application
ANDA214089
TE code
AB
Approval date
Oct 1, 2021
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 mexiletine hydrochloride (Capsule)

LabelerStrengthFirst seenLast seen
Bryant Ranch PrepackMEXILETINE HYDROCHLORIDE 250 mg/1Jul 15, 2026Sep 3, 2026
Bryant Ranch PrepackMEXILETINE HYDROCHLORIDE 200 mg/1Jul 15, 2026Sep 3, 2026
Bryant Ranch PrepackMEXILETINE HYDROCHLORIDE 150 mg/1Jul 15, 2026Sep 3, 2026
Teva Pharmaceuticals USA, Inc.MEXILETINE HYDROCHLORIDE 200 mg/1Jul 15, 2026Sep 3, 2026
Teva Pharmaceuticals USA, Inc.MEXILETINE HYDROCHLORIDE 250 mg/1Jul 15, 2026Sep 3, 2026
Teva Pharmaceuticals USA, Inc.MEXILETINE HYDROCHLORIDE 150 mg/1Jul 15, 2026Sep 3, 2026
American Health PackagingMEXILETINE HYDROCHLORIDE 150 mg/1Jul 15, 2026Sep 2, 2026
ANI Pharmaceuticals, Inc.MEXILETINE HYDROCHLORIDE 150 mg/1Jul 15, 2026Sep 2, 2026
ANI Pharmaceuticals, Inc.MEXILETINE HYDROCHLORIDE 250 mg/1Jul 15, 2026Sep 2, 2026
ANI Pharmaceuticals, Inc.MEXILETINE HYDROCHLORIDE 200 mg/1Jul 15, 2026Sep 2, 2026
AvKAREMEXILETINE HYDROCHLORIDE 250 mg/1Jul 15, 2026Sep 2, 2026
AvKAREMEXILETINE HYDROCHLORIDE 150 mg/1Jul 15, 2026Sep 2, 2026
AvKAREMEXILETINE HYDROCHLORIDE 200 mg/1Jul 15, 2026Sep 2, 2026
Camber Pharmaceuticals, Inc.MEXILETINE HYDROCHLORIDE 200 mg/1Jul 15, 2026Sep 2, 2026
Camber Pharmaceuticals, Inc.MEXILETINE HYDROCHLORIDE 250 mg/1Jul 15, 2026Sep 2, 2026
Camber Pharmaceuticals, Inc.MEXILETINE HYDROCHLORIDE 150 mg/1Jul 15, 2026Sep 2, 2026
Chartwell RX, LLCMEXILETINE HYDROCHLORIDE 250 mg/1Jul 15, 2026Sep 2, 2026
Golden State Medical Supply, Inc.MEXILETINE HYDROCHLORIDE 150 mg/1Jul 15, 2026Sep 2, 2026
Golden State Medical Supply, Inc.MEXILETINE HYDROCHLORIDE 200 mg/1Jul 15, 2026Sep 2, 2026
Golden State Medical Supply, Inc.MEXILETINE HYDROCHLORIDE 250 mg/1Jul 15, 2026Sep 2, 2026
Ingenus Pharmaceuticals, LLCMEXILETINE HYDROCHLORIDE 250 mg/1Jul 15, 2026Sep 2, 2026
Ingenus Pharmaceuticals, LLCMEXILETINE HYDROCHLORIDE 200 mg/1Jul 15, 2026Sep 2, 2026
Ingenus Pharmaceuticals, LLCMEXILETINE HYDROCHLORIDE 150 mg/1Jul 15, 2026Sep 2, 2026
Macleods Pharmaceuticals LimitedMEXILETINE HYDROCHLORIDE 200 mg/1Jul 15, 2026Sep 2, 2026
Macleods Pharmaceuticals LimitedMEXILETINE HYDROCHLORIDE 150 mg/1Jul 15, 2026Sep 2, 2026
Macleods Pharmaceuticals LimitedMEXILETINE HYDROCHLORIDE 250 mg/1Jul 15, 2026Sep 2, 2026
Rising Pharma Holdings, Inc.MEXILETINE HYDROCHLORIDE 150 mg/1Jul 15, 2026Sep 2, 2026
Rising Pharma Holdings, Inc.MEXILETINE HYDROCHLORIDE 200 mg/1Jul 15, 2026Sep 2, 2026
Rising Pharma Holdings, Inc.MEXILETINE HYDROCHLORIDE 250 mg/1Jul 15, 2026Sep 2, 2026
Senores Pharmaceuticals, Inc.MEXILETINE HYDROCHLORIDE 250 mg/1Jul 15, 2026Sep 2, 2026
Senores Pharmaceuticals, Inc.MEXILETINE HYDROCHLORIDE 200 mg/1Jul 15, 2026Sep 2, 2026
Senores Pharmaceuticals, Inc.MEXILETINE HYDROCHLORIDE 150 mg/1Jul 15, 2026Sep 2, 2026
Sun Pharmaceutical Industries, Inc.MEXILETINE HYDROCHLORIDE 250 mg/1Jul 15, 2026Sep 2, 2026
Sun Pharmaceutical Industries, Inc.MEXILETINE HYDROCHLORIDE 150 mg/1Jul 15, 2026Sep 2, 2026
Sun Pharmaceutical Industries, Inc.MEXILETINE HYDROCHLORIDE 200 mg/1Jul 15, 2026Sep 2, 2026
Amerisyn LLCMEXILETINE HYDROCHLORIDE 250 mg/1Aug 18, 2026Sep 1, 2026
Amerisyn LLCMEXILETINE HYDROCHLORIDE 200 mg/1Aug 18, 2026Sep 1, 2026
Amerisyn LLCMEXILETINE HYDROCHLORIDE 150 mg/1Aug 18, 2026Sep 1, 2026

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

Cite this page

DrugDashboards, "Mexiletine Hydrochloride — NDC 87564-0054-10," retrieved September 3, 2026, https://drugdashboards.com/drug/87564005410.

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