Viewing data from:

SORINE

ANDA

SOTALOL HYDROCHLORIDE | A075500 | AIPING PHARMACEUTICAL INC

4 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: BETAPACE(TE code: AB)

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-10-21 | 4 NDCs

Highest NADAC/Unit

$0.2074

per ea

Lowest NADAC/Unit

$0.0706

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
11788005401SOTALOL 240 MG TABLET	$0.2074	EA	Generic	—	2026-10-21
11788005301SOTALOL 160 MG TABLET	$0.1300	EA	Generic	—	2026-10-21
11788005201SOTALOL 120 MG TABLET	$0.1048	EA	Generic	—	2026-10-21
11788005101SOTALOL 80 MG TABLET	$0.0706	EA	Generic	—	2026-10-21

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.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Apr 27, 2001	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 80MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Apr 27, 2001

No patent or exclusivity listings for this strength.

#002 — 160MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Apr 27, 2001

#003 — 240MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Apr 27, 2001

#004 — 120MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Apr 27, 2001