MedPath

Torsemide

These highlights do not include all the information needed to use TORSEMIDE TABLETS safely and effectively. See full prescribing information for TORSEMIDE TABLETS TORSEMIDE tablets, for oral use Initial U.S. Approval: 1993

Approved
Approval ID

3c8f1c0b-8a44-4ca0-b2cf-3c591f8878fd

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jun 14, 2023

Manufacturers
FDA

Rising Health, LLC

DUNS: 080500961

Products 4

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 Code57237-141
Application NumberANDA078249
Product Classification
M
Marketing Category
C73584
G
Generic Name
Torsemide
Product Specifications
Route of AdministrationORAL
Effective DateJune 14, 2023
FDA Product Classification

INGREDIENTS (6)

MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
TORSEMIDEActive
Quantity: 100 mg in 1 1
Code: W31X2H97FB
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT

Torsemide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code57237-139
Application NumberANDA078249
Product Classification
M
Marketing Category
C73584
G
Generic Name
Torsemide
Product Specifications
Route of AdministrationORAL
Effective DateJune 14, 2023
FDA Product Classification

INGREDIENTS (6)

TORSEMIDEActive
Quantity: 10 mg in 1 1
Code: W31X2H97FB
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT

Torsemide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code57237-138
Application NumberANDA078249
Product Classification
M
Marketing Category
C73584
G
Generic Name
Torsemide
Product Specifications
Route of AdministrationORAL
Effective DateJune 14, 2023
FDA Product Classification

INGREDIENTS (6)

LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
TORSEMIDEActive
Quantity: 5 mg in 1 1
Code: W31X2H97FB
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT

Torsemide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code57237-140
Application NumberANDA078249
Product Classification
M
Marketing Category
C73584
G
Generic Name
Torsemide
Product Specifications
Route of AdministrationORAL
Effective DateJune 14, 2023
FDA Product Classification

INGREDIENTS (6)

TORSEMIDEActive
Quantity: 20 mg in 1 1
Code: W31X2H97FB
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.