BETAPACE
These highlights do not include all the information needed to use BETAPACE/BETAPACE AF safely and effectively. See full prescribing information for BETAPACE/BETAPACE AF. BETAPACE (sotalol hydrochloride) tablets, for oral useBETAPACE AF (sotalol hydrochloride) tablets, for oral useInitial U.S. Approval: 1992
Approved
Approval ID
afce2787-8899-4098-87c8-f1e8dd19e6dd
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 15, 2023
Manufacturers
FDA
Covis Pharma US, Inc
DUNS: 118094829
Products 6
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 Code70515-119
Application NumberNDA021151
Product Classification
M
Marketing Category
C73594
G
Generic Name
sotalol hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateAugust 10, 2018
FDA Product Classification
INGREDIENTS (7)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SOTALOL HYDROCHLORIDEActive
Quantity: 120 mg in 1 1
Code: HEC37C70XX
Classification: ACTIB
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
sotalol hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70515-106
Application NumberNDA019865
Product Classification
M
Marketing Category
C73594
G
Generic Name
sotalol hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateAugust 10, 2018
FDA Product Classification
INGREDIENTS (8)
SOTALOL HYDROCHLORIDEActive
Quantity: 160 mg in 1 1
Code: HEC37C70XX
Classification: ACTIB
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
sotalol hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70515-115
Application NumberNDA021151
Product Classification
M
Marketing Category
C73594
G
Generic Name
sotalol hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateAugust 10, 2018
FDA Product Classification
INGREDIENTS (7)
SOTALOL HYDROCHLORIDEActive
Quantity: 80 mg in 1 1
Code: HEC37C70XX
Classification: ACTIB
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
sotalol hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70515-116
Application NumberNDA021151
Product Classification
M
Marketing Category
C73594
G
Generic Name
sotalol hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateAugust 10, 2018
FDA Product Classification
INGREDIENTS (7)
SOTALOL HYDROCHLORIDEActive
Quantity: 160 mg in 1 1
Code: HEC37C70XX
Classification: ACTIB
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
sotalol hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70515-109
Application NumberNDA019865
Product Classification
M
Marketing Category
C73594
G
Generic Name
sotalol hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateAugust 10, 2018
FDA Product Classification
INGREDIENTS (8)
SOTALOL HYDROCHLORIDEActive
Quantity: 120 mg in 1 1
Code: HEC37C70XX
Classification: ACTIB
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
sotalol hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70515-105
Application NumberNDA019865
Product Classification
M
Marketing Category
C73594
G
Generic Name
sotalol hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateAugust 10, 2018
FDA Product Classification
INGREDIENTS (8)
SOTALOL HYDROCHLORIDEActive
Quantity: 80 mg in 1 1
Code: HEC37C70XX
Classification: ACTIB
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT