Sotalol Hydrochloride
Sotalol Hydrochloride Tablets, USP (AF) 80 mg, 120 mg, and 160 mg
Approved
Approval ID
2577dd8d-ab1b-4a55-990a-18c69395edfe
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 Tables AF
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code76385-126
Application NumberANDA207429
Product Classification
M
Marketing Category
C73584
G
Generic Name
Sotalol Hydrochloride Tables AF
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 24, 2020
FDA Product Classification
INGREDIENTS (7)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
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 HYDROCHLORIDEActive
Quantity: 120 mg in 1 1
Code: HEC37C70XX
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
Sotalol Hydrochloride Tablets AF
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code76385-127
Application NumberANDA207429
Product Classification
M
Marketing Category
C73584
G
Generic Name
Sotalol Hydrochloride Tablets AF
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 24, 2020
FDA Product Classification
INGREDIENTS (7)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SOTALOL HYDROCHLORIDEActive
Quantity: 160 mg in 1 1
Code: HEC37C70XX
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
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 Tables AF
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code76385-125
Application NumberANDA207429
Product Classification
M
Marketing Category
C73584
G
Generic Name
Sotalol Hydrochloride Tables AF
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 24, 2020
FDA Product Classification
INGREDIENTS (7)
SOTALOL HYDROCHLORIDEActive
Quantity: 80 mg in 1 1
Code: HEC37C70XX
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
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