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SOTALOL HYDROCHLORIDE

ANDA

SOTALOL HYDROCHLORIDE | A207428 | REGCON HOLDINGS LLC

3 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: BETAPACE(TE code: AB)

Drug Pricing (NADAC)

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

Highest NADAC/Unit

$0.1351

per ea

Lowest NADAC/Unit

$0.0695

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
76385011601SOTALOL 160 MG TABLET	$0.1351	EA	Generic	—	2026-08-19
76385011501SOTALOL 120 MG TABLET	$0.1106	EA	Generic	—	2026-08-19
76385011401SOTALOL 80 MG TABLET	$0.0695	EA	Generic	—	2026-08-19

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

API Supply Chain2 active DMFs5 inactive

2 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

SIEGFRIED LTDSOTALOL HYDROCHLORIDE

DMF 37211980

NEULAND LABORATORIES LTDSOTALOL HYDROCHLORIDE USP

DMF 149512000

IROTEC LABORATORIESInactiveSOTALOL HYDROCHLORIDE

DMF 118871996

ERREGIERRE SPAInactiveSOTALOL HYDROCHLORIDE

DMF 130831998

HEUMANN PHARMA GMBHInactiveSOTALOL HYDROCHLORIDE

DMF 131861998

SIFAVITOR SRLInactiveSOTALOL HYDROCHLORIDE

DMF 148412000

AREVIPHARMA GMBHInactiveSOTALOL HYDROCHLORIDE

DMF 237522010

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

Products (3)

Sort:

#001 — 80MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Oct 21, 2016

No patent or exclusivity listings for this strength.

#002 — 120MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Oct 21, 2016

#003 — 160MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Oct 21, 2016