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SOTALOL HYDROCHLORIDE

ANDA

SOTALOL HYDROCHLORIDE | A075429 | TEVA PHARMACEUTICALS USA INC

4 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: BETAPACE(TE code: AB)

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 4 NDCs

Highest NADAC/Unit

$0.1628

per ea

Lowest NADAC/Unit

$0.0695

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00093106301SOTALOL 240 MG TABLET	$0.1628	EA	Generic	—	2026-06-17
00093106201SOTALOL 160 MG TABLET	$0.1466	EA	Generic	—	2026-06-17
00093106001SOTALOL 120 MG TABLET	$0.1051	EA	Generic	—	2026-06-17
00093106101SOTALOL 80 MG TABLET	$0.0695	EA	Generic	—	2026-06-17

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

VA Federal Supply Schedule

Government-negotiated contract prices | 4 NDCs (4 FSS)

Lowest Price

$4.15

Highest Price

$27.92

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00093-1060-01SOTALOL HCL 120MG TAB	$9.54	FSS	AvKare, LLC	06/14/2028
00093-1061-01SOTALOL HCL 80MG TAB	$4.15	FSS	AvKare, LLC	06/14/2028
00093-1062-01SOTALOL HCL 160MG TAB	$12.40	FSS	AvKare, LLC	06/14/2028
00093-1063-01SOTALOL HCL 240MG TAB	$27.92	FSS	AvKare, LLC	06/14/2028

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

API Supply Chain3 active DMFs5 inactive

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

SIEGFRIED LTDSOTALOL HYDROCHLORIDE

DMF 37211980

NEULAND LABORATORIES LTDSOTALOL HYDROCHLORIDE USP

DMF 149512000

APISYN HEALTHCARE PRIVATE LTDSOTALOL HYDROCHLORIDE USP

DMF 434032026

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.

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Jun 17, 2004	ORIG -1	View Letter (PDF)
May 1, 2000	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 80MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: May 1, 2000

No patent or exclusivity listings for this strength.

#002 — 120MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: May 1, 2000

#003 — 160MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: May 1, 2000

#004 — 240MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: May 1, 2000