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DAPSONE

ANDA

DAPSONE | A209890 | AMNEAL PHARMACEUTICALS LLC

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: ACZONE(TE code: AB)

Drug Pricing (NADAC)

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

Highest NADAC/Unit

$0.7335

per gm

Lowest NADAC/Unit

$0.6700

per gm

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
65162033985DAPSONE 5% GEL	$0.7335	GM	Generic	—	2026-08-19
65162033991DAPSONE 5% GEL	$0.6700	GM	Generic	—	2026-08-19

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

API Supply Chain12 active DMFs3 inactive

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

LUNDBECK PHARMACEUTICALS ITALY SPADAPSONE

DMF 150652000

ATUL LTDDAPSONE USP

DMF 177812004

NOVITIUM PHARMA LLCDAPSONE USP

DMF 276782013

SAI LIFE SCIENCES LTDDAPSONE USP

DMF 277012013

TARO PHARMACEUTICAL INDUSTRIES LTDDAPSONE USP

DMF 299992016

DIPHARMA FRANCIS SRLDAPSONE

DMF 315212017

MACLEODS PHARMACEUTICALS LTDDAPSONE

DMF 332282019

EXTROVIS AGDAPSONE

DMF 336302019

MACLEODS PHARMACEUTICALS LTDDAPSONE USP

DMF 352442021

COHANCE LIFESCIENCES LTDDAPSONE USP

DMF 353422020

MEDILUX LABORATORIES PVT LTDDAPSONE USP

DMF 383782023

CHONGQING HUAPONT PHARMACEUTICAL CO LTDDAPSONE

DMF 384832023

JACOBUS PHARMACEUTICAL COInactiveDAPSONE (FINAL DOSAGE FORMS)

DMF 74131988

REGIS TECHNOLOGIES INCInactiveDAPSONE, USP

DMF 250892011

MEDILUX LABORATORIES PVT LTDInactiveDAPSONE USP

DMF 357862022

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

Products (1)

#001 — 5%

0 patents0 exclusivities▴

GEL;TOPICAL | Approved: Oct 19, 2023

No patent or exclusivity listings for this strength.