Sotalol
These highlights do not include all the information needed to use SOTALOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SOTALOL HYDROCHLORIDE TABLETS.SOTALOL HYDROCHLORIDE tablets, for oral useInitial U.S. Approval: 1992
Approved
Approval ID
56879738-8662-4f5c-8386-761ab2b5e46f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 17, 2024
Manufacturers
FDA
Bayshore Pharmaceuticals LLC
DUNS: 968737416
Products 3
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 Code76385-115
Application NumberANDA207428
Product Classification
M
Marketing Category
C73584
G
Generic Name
Sotalol Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 6, 2017
FDA Product Classification
INGREDIENTS (8)
SOTALOL HYDROCHLORIDEActive
Quantity: 120 mg in 1 1
Code: HEC37C70XX
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Sotalol Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code76385-114
Application NumberANDA207428
Product Classification
M
Marketing Category
C73584
G
Generic Name
Sotalol Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 6, 2017
FDA Product Classification
INGREDIENTS (8)
SOTALOL HYDROCHLORIDEActive
Quantity: 80 mg in 1 1
Code: HEC37C70XX
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Sotalol Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code76385-116
Application NumberANDA207428
Product Classification
M
Marketing Category
C73584
G
Generic Name
Sotalol Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 6, 2017
FDA Product Classification
INGREDIENTS (8)
SOTALOL HYDROCHLORIDEActive
Quantity: 160 mg in 1 1
Code: HEC37C70XX
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT