Sotalol Hydrochloride
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 use Initial U.S. Approval: 1992
Approved
Approval ID
c8ac6351-b1e9-4dd2-82f2-5980814fda15
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 2, 2023
Manufacturers
FDA
Oxford Pharmaceuticals, LLC
DUNS: 079638266
Products 4
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 Code69584-842
Application NumberANDA075563
Product Classification
M
Marketing Category
C73584
G
Generic Name
Sotalol Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateNovember 2, 2023
FDA Product Classification
INGREDIENTS (8)
Lactose MonohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
SOTALOL HYDROCHLORIDEActive
Quantity: 120 mg in 1 1
Code: HEC37C70XX
Classification: ACTIB
Silicon DioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
Sodium Starch Glycolate Type A PotatoInactive
Code: 5856J3G2A2
Classification: IACT
Stearic AcidInactive
Code: 4ELV7Z65AP
Classification: IACT
Fd&C Blue No. 2--Aluminum LakeInactive
Code: 4AQJ3LG584
Classification: IACT
Microcrystalline Cellulose 102Inactive
Code: PNR0YF693Y
Classification: IACT
Sotalol Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69584-841
Application NumberANDA075563
Product Classification
M
Marketing Category
C73584
G
Generic Name
Sotalol Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateNovember 2, 2023
FDA Product Classification
INGREDIENTS (8)
SOTALOL HYDROCHLORIDEActive
Quantity: 80 mg in 1 1
Code: HEC37C70XX
Classification: ACTIB
Silicon DioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
Lactose MonohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
Microcrystalline Cellulose 102Inactive
Code: PNR0YF693Y
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
Sodium Starch Glycolate Type A PotatoInactive
Code: 5856J3G2A2
Classification: IACT
Stearic AcidInactive
Code: 4ELV7Z65AP
Classification: IACT
Fd&C Blue No. 2--Aluminum LakeInactive
Code: 4AQJ3LG584
Classification: IACT
Sotalol Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69584-843
Application NumberANDA075563
Product Classification
M
Marketing Category
C73584
G
Generic Name
Sotalol Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateNovember 2, 2023
FDA Product Classification
INGREDIENTS (8)
SOTALOL HYDROCHLORIDEActive
Quantity: 160 mg in 1 1
Code: HEC37C70XX
Classification: ACTIB
Silicon DioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
Lactose MonohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
Stearic AcidInactive
Code: 4ELV7Z65AP
Classification: IACT
Fd&C Blue No. 2--Aluminum LakeInactive
Code: 4AQJ3LG584
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
Microcrystalline Cellulose 102Inactive
Code: PNR0YF693Y
Classification: IACT
Sodium Starch Glycolate Type A PotatoInactive
Code: 5856J3G2A2
Classification: IACT
Sotalol Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69584-844
Application NumberANDA075563
Product Classification
M
Marketing Category
C73584
G
Generic Name
Sotalol Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateNovember 2, 2023
FDA Product Classification
INGREDIENTS (8)
Lactose MonohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
SOTALOL HYDROCHLORIDEActive
Quantity: 240 mg in 1 1
Code: HEC37C70XX
Classification: ACTIB
Silicon DioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
Microcrystalline Cellulose 102Inactive
Code: PNR0YF693Y
Classification: IACT
Sodium Starch Glycolate Type A PotatoInactive
Code: 5856J3G2A2
Classification: IACT
Stearic AcidInactive
Code: 4ELV7Z65AP
Classification: IACT
Fd&C Blue No. 2--Aluminum LakeInactive
Code: 4AQJ3LG584
Classification: IACT