Viewing data from:

MEXILETINE HYDROCHLORIDE

ANDA

MEXILETINE HYDROCHLORIDE | A074450 | ANI PHARMACEUTICALS INC

3 strengths0 unique patents0 unique exclusivities

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-08-26 | 3 NDCs

Highest NADAC/Unit

$0.3938

per ea

Lowest NADAC/Unit

$0.2266

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
62559082201MEXILETINE 250 MG CAPSULE	$0.3938	EA	Generic	—	2026-08-19
62559082101MEXILETINE 200 MG CAPSULE	$0.2627	EA	Generic	—	2026-08-19
62559082001MEXILETINE 150 MG CAPSULE	$0.2266	EA	Generic	—	2026-08-19

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

VA Federal Supply Schedule

Government-negotiated contract prices | 3 NDCs (3 FSS)

Lowest Price

$54.24

Highest Price

$77.72

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
51407-0379-01MEXILETINE HCL 150MG CAP	$54.24	FSS	Golden State Medical Supply, Inc.	06/14/2028
51407-0380-01MEXILETINE HCL 200MG CAP	$56.53	FSS	Golden State Medical Supply, Inc.	06/14/2028
51407-0381-01MEXILETINE HCL 250MG CAP	$77.72	FSS	Golden State Medical Supply, Inc.	06/14/2028

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

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: May 16, 1996

No patent or exclusivity listings for this strength.

#002 — 200MG

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: May 16, 1996

#003 — 250MG

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: May 16, 1996