SOAANZ
These highlights do not include all the information needed to use SOAANZ® safely and effectively. See full prescribing information for SOAANZ. SOAANZ (torsemide) tablets, for oral use Initial U.S. Approval: 1993
Approved
Approval ID
05eaa163-b6e9-438a-85f8-6a60e743d460
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 16, 2024
Manufacturers
FDA
Sarfez Pharmaceuticals Inc
DUNS: 047963902
Products 6
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Torsemide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code73502-287
Application NumberNDA213218
Product Classification
M
Marketing Category
C73594
G
Generic Name
Torsemide
Product Specifications
Route of AdministrationORAL
Effective DateDecember 28, 2021
FDA Product Classification
INGREDIENTS (10)
TorsemideActive
Quantity: 40 mg in 1 1
Code: W31X2H97FB
Classification: ACTIB
Silicon DioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
Ferric Oxide YellowInactive
Code: EX438O2MRT
Classification: IACT
Ferric Oxide RedInactive
Code: 1K09F3G675
Classification: IACT
Lactose, unspecified formInactive
Code: J2B2A4N98G
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
Microcrystalline Cellulose 101Inactive
Code: 7T9FYH5QMK
Classification: IACT
TalcInactive
Code: 7SEV7J4R1U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
Torsemide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code73502-286
Application NumberNDA213218
Product Classification
M
Marketing Category
C73594
G
Generic Name
Torsemide
Product Specifications
Route of AdministrationORAL
Effective DateDecember 28, 2021
FDA Product Classification
INGREDIENTS (10)
TorsemideActive
Quantity: 20 mg in 1 1
Code: W31X2H97FB
Classification: ACTIB
Ferric Oxide YellowInactive
Code: EX438O2MRT
Classification: IACT
Silicon DioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
Ferric Oxide RedInactive
Code: 1K09F3G675
Classification: IACT
Lactose, unspecified formInactive
Code: J2B2A4N98G
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
TalcInactive
Code: 7SEV7J4R1U
Classification: IACT
Microcrystalline Cellulose 101Inactive
Code: 7T9FYH5QMK
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
Torsemide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code73502-586
Application NumberNDA213218
Product Classification
M
Marketing Category
C73594
G
Generic Name
Torsemide
Product Specifications
Route of AdministrationORAL
Effective DateDecember 28, 2021
FDA Product Classification
INGREDIENTS (10)
Ferric Oxide RedInactive
Code: 1K09F3G675
Classification: IACT
Silicon DioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
TorsemideActive
Quantity: 40 mg in 1 1
Code: W31X2H97FB
Classification: ACTIB
Ferric Oxide YellowInactive
Code: EX438O2MRT
Classification: IACT
Lactose, unspecified formInactive
Code: J2B2A4N98G
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
Microcrystalline Cellulose 101Inactive
Code: 7T9FYH5QMK
Classification: IACT
TalcInactive
Code: 7SEV7J4R1U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
Torsemide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code73502-786
Application NumberNDA213218
Product Classification
M
Marketing Category
C73594
G
Generic Name
Torsemide
Product Specifications
Route of AdministrationORAL
Effective DateDecember 28, 2021
FDA Product Classification
INGREDIENTS (10)
Silicon DioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
TorsemideActive
Quantity: 20 mg in 1 1
Code: W31X2H97FB
Classification: ACTIB
Ferric Oxide RedInactive
Code: 1K09F3G675
Classification: IACT
Ferric Oxide YellowInactive
Code: EX438O2MRT
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
TalcInactive
Code: 7SEV7J4R1U
Classification: IACT
Lactose, unspecified formInactive
Code: J2B2A4N98G
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
Microcrystalline Cellulose 101Inactive
Code: 7T9FYH5QMK
Classification: IACT
Torsemide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code73502-687
Application NumberNDA213218
Product Classification
M
Marketing Category
C73594
G
Generic Name
Torsemide
Product Specifications
Route of AdministrationORAL
Effective DateDecember 28, 2021
FDA Product Classification
INGREDIENTS (10)
Silicon DioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
TorsemideActive
Quantity: 60 mg in 1 1
Code: W31X2H97FB
Classification: ACTIB
Ferric Oxide YellowInactive
Code: EX438O2MRT
Classification: IACT
Ferric Oxide RedInactive
Code: 1K09F3G675
Classification: IACT
Lactose, unspecified formInactive
Code: J2B2A4N98G
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
Microcrystalline Cellulose 101Inactive
Code: 7T9FYH5QMK
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
TalcInactive
Code: 7SEV7J4R1U
Classification: IACT
Torsemide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code73502-288
Application NumberNDA213218
Product Classification
M
Marketing Category
C73594
G
Generic Name
Torsemide
Product Specifications
Route of AdministrationORAL
Effective DateDecember 28, 2021
FDA Product Classification
INGREDIENTS (10)
TorsemideActive
Quantity: 60 mg in 1 1
Code: W31X2H97FB
Classification: ACTIB
Silicon DioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
Lactose, unspecified formInactive
Code: J2B2A4N98G
Classification: IACT
Ferric Oxide RedInactive
Code: 1K09F3G675
Classification: IACT
Microcrystalline Cellulose 101Inactive
Code: 7T9FYH5QMK
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
TalcInactive
Code: 7SEV7J4R1U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
Ferric Oxide YellowInactive
Code: EX438O2MRT
Classification: IACT