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MEXILETINE HYDROCHLORIDE

ANDA

MEXILETINE HYDROCHLORIDE | A214352 | INGENUS PHARMACEUTICALS LLC

3 strengths0 unique patents0 unique exclusivities

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 3 NDCs

Highest NADAC/Unit

$0.4464

per ea

Lowest NADAC/Unit

$0.2387

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
50742024101MEXILETINE 250 MG CAPSULE	$0.4464	EA	Generic	—	2026-06-17
50742024001MEXILETINE 200 MG CAPSULE	$0.2651	EA	Generic	—	2026-06-17
50742023901MEXILETINE 150 MG CAPSULE	$0.2387	EA	Generic	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

API Supply Chain7 active DMFs3 inactive

7 active API suppliers hold Drug Master Files for this ingredient.

MEDICHEM SAMEXILETINE HYDROCHLORIDE

DMF 92571991

ALEMBIC PHARMACEUTICALS LTDMEXILETINE HYDROCHLORIDE USP

DMF 247142011

BIOPHORE INDIA PHARMACEUTICALS PVT LTDMEXILETINE HYDROCHLORIDE

DMF 346682020

COHANCE LIFESCIENCES LTDMEXILETINE HYDROCHLORIDE USP

DMF 349582020

KALINTIS HEALTHCARE PVT LTDMEXILETINE HYDROCHLORIDE USP

DMF 351462020

HETERO DRUGS LTDMEXILETINE HYDROCHLORIDE

DMF 359832021

MACLEODS PHARMACEUTICALS LTDMEXILETINE HYDROCHLORIDE USP

DMF 360972021

FINE CHEMICALS CORPInactiveMEXILETINE HYDROCHLORIDE

DMF 97861992

ICN HUNGARY COMPANY LTDInactiveMEXILETINE HYDROCHLORIDE USP BULK

DMF 103761993

SLOVAKOFARMA ASInactiveMEXILETINE HYDROCHLORIDE

DMF 144421999

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Products (3)

Sort:

#001 — 150MG

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Jan 25, 2021

No patent or exclusivity listings for this strength.

#002 — 200MG

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Jan 25, 2021

#003 — 250MG

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Jan 25, 2021