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Sotalol Hydrochloride

These highlights do not include all the information needed to use SOTALOL HYDROCHLORIDE/SOTALOL HYDROCHLORIDE AF TABLETS safely and effectively. See full prescribing information for SOTALOL HYDROCHLORIDE/SOTALOL HYDROCHLORIDE AF TABLETS SOTALOL HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1992 SOTALOL HYDROCHLORIDE AF tablets, for oral use Initial U.S. Approval: 1992

Approved
Approval ID

1a56c82e-7ecd-43b0-2899-f89e47adf7db

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jul 5, 2023

Manufacturers
FDA

Apotex Corp.

DUNS: 845263701

Products 7

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Sotalol Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code60505-0081
Application NumberANDA076140
Product Classification
M
Marketing Category
C73584
G
Generic Name
Sotalol Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJuly 5, 2023
FDA Product Classification

INGREDIENTS (3)

SOTALOL HYDROCHLORIDEActive
Quantity: 160 mg in 1 1
Code: HEC37C70XX
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT

Sotalol Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code60505-0222
Application NumberANDA076214
Product Classification
M
Marketing Category
C73584
G
Generic Name
Sotalol Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJuly 5, 2023
FDA Product Classification

INGREDIENTS (3)

SOTALOL HYDROCHLORIDEActive
Quantity: 80 mg in 1 1
Code: HEC37C70XX
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT

Sotalol Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code60505-0159
Application NumberANDA076140
Product Classification
M
Marketing Category
C73584
G
Generic Name
Sotalol Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJuly 5, 2023
FDA Product Classification

INGREDIENTS (3)

SOTALOL HYDROCHLORIDEActive
Quantity: 120 mg in 1 1
Code: HEC37C70XX
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT

Sotalol Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code60505-0223
Application NumberANDA076214
Product Classification
M
Marketing Category
C73584
G
Generic Name
Sotalol Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJuly 5, 2023
FDA Product Classification

INGREDIENTS (3)

MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SOTALOL HYDROCHLORIDEActive
Quantity: 120 mg in 1 1
Code: HEC37C70XX
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT

Sotalol Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code60505-0224
Application NumberANDA076214
Product Classification
M
Marketing Category
C73584
G
Generic Name
Sotalol Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJuly 5, 2023
FDA Product Classification

INGREDIENTS (3)

SOTALOL HYDROCHLORIDEActive
Quantity: 160 mg in 1 1
Code: HEC37C70XX
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT

Sotalol Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code60505-0082
Application NumberANDA076140
Product Classification
M
Marketing Category
C73584
G
Generic Name
Sotalol Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJuly 5, 2023
FDA Product Classification

INGREDIENTS (3)

SOTALOL HYDROCHLORIDEActive
Quantity: 240 mg in 1 1
Code: HEC37C70XX
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT

Sotalol Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code60505-0080
Application NumberANDA076140
Product Classification
M
Marketing Category
C73584
G
Generic Name
Sotalol Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJuly 5, 2023
FDA Product Classification

INGREDIENTS (3)

SOTALOL HYDROCHLORIDEActive
Quantity: 80 mg in 1 1
Code: HEC37C70XX
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT

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