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RUFINAMIDE

ANDA

RUFINAMIDE | A216841 | HETERO LABS LTD UNIT III

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: BANZEL(TE code: AB)

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-08-26 | 2 NDCs

Highest NADAC/Unit

$0.2036

per ml

Lowest NADAC/Unit

$0.2036

per ml

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
72603026101RUFINAMIDE 40 MG/ML SUSPENSION	$0.2036	ML	Generic	—	2026-08-19
31722068846RUFINAMIDE 40 MG/ML SUSPENSION	$0.2036	ML	Generic	—	2026-08-19

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

API Supply Chain8 active DMFs1 inactive

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

DIPHARMA FRANCIS SRLRUFINAMIDE USP

DMF 256762012

ALIVUS LIFE SCIENCES LTDRUFINAMIDE

DMF 262092012

LUPIN MANUFACTURING SOLUTIONS LTDRUFINAMIDE USP

DMF 263162012

MSN LABORATORIES PRIVATE LTDRUFINAMIDE USP [ROUTE CODE "RU"]

DMF 263852012

APOTEX INCRUFINAMIDE USP

DMF 290342015

MSN LIFE SCIENCES PRIVATE LTDRUFINAMIDE USP

DMF 327132018

HETERO DRUGS LTDRUFINAMIDE

DMF 360772021

MICRO LABS LTDRUFINAMIDE USP

DMF 381822023

ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTDInactiveRUFINAMIDE

DMF 282842014

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

Products (1)

#001 — 40MG/ML

0 patents0 exclusivities▴

SUSPENSION;ORAL | Approved: Dec 5, 2023

No patent or exclusivity listings for this strength.