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FLECAINIDE ACETATE

ANDA

FLECAINIDE ACETATE | A075442 | AMNEAL PHARMACEUTICAL

3 strengths0 unique patents0 unique exclusivities

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-08-26 | 5 NDCs

Highest NADAC/Unit

$0.2590

per ea

Lowest NADAC/Unit

$0.1118

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
53746064301FLECAINIDE ACETATE 150 MG TAB	$0.2590	EA	Generic	—	2026-08-19
53746064201FLECAINIDE ACETATE 100 MG TAB	$0.1737	EA	Generic	—	2026-08-19
50268032115FLECAINIDE ACETATE 100 MG TAB	$0.1737	EA	Generic	—	2026-08-19
53746064101FLECAINIDE ACETATE 50 MG TAB	$0.1118	EA	Generic	—	2026-08-19
50268032015FLECAINIDE ACETATE 50 MG TAB	$0.1118	EA	Generic	—	2026-08-19

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

API Supply Chain10 active DMFs2 inactive

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

MAPRIMED SAFLECAINIDE ACETATE PROCESS I (CODE 50064)

DMF 106881994

AMSA ANONIMA MATERIE SINTETICHE AND AFFINI SPAFLECAINIDE ACETATE

DMF 147492000

UNIMARK REMEDIES LTDFLECAINIDE ACETATE USP

DMF 192722006

UNIMARK REMEDIES LTDFLECAINIDE ACETATE USP (PROCESS B)

DMF 231922009

EMCURE PHARMACEUTICALS LTDFLECAINIDE ACETATE USP

DMF 278592014

MAPRIMED SAFLECAINIDE ACETATE PROCESS III (CODE 50970)

DMF 281582014

APITORIA PHARMA PRIVATE LTDFLECAINIDE ACETATE USP

DMF 317572017

SOLARA ACTIVE PHARMA SCIENCES LTDFLECAINIDE ACETATE USP

DMF 336662019

MSN LIFE SCIENCES PRIVATE LTDFLECAINIDE ACETATE USP

DMF 357602021

OMSAV PHARMA RESEARCH PRIVATE LTDFLECAINIDE ACETATE USP

DMF 372122022

POLYCARBON INDUSTRIES INC DBA PCI SYNTHESISInactiveFLECAINIDE ACETATE USP

DMF 152442001

MAPRIMED SAInactiveFLECAINIDE ACETATE PROCESS II (CODE 50856)

DMF 243092010

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

Products (3)

Sort:

#001 — 50MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jul 31, 2001

No patent or exclusivity listings for this strength.

#002 — 100MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jul 31, 2001

#003 — 150MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jul 31, 2001