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
55e88727-864e-4313-860c-31a6ca45168f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 14, 2023
Manufacturers
FDA
Aurobindo Pharma Limited
DUNS: 650082092
Products 4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Torsemide
PRODUCT DETAILS
NDC Product Code65862-125
Application NumberANDA078249
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJune 14, 2023
Generic NameTorsemide
INGREDIENTS (6)
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
TORSEMIDEActive
Quantity: 5 mg in 1 1
Code: W31X2H97FB
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
Torsemide
PRODUCT DETAILS
NDC Product Code65862-126
Application NumberANDA078249
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJune 14, 2023
Generic NameTorsemide
INGREDIENTS (6)
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
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
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Torsemide
PRODUCT DETAILS
NDC Product Code65862-127
Application NumberANDA078249
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJune 14, 2023
Generic NameTorsemide
INGREDIENTS (6)
TORSEMIDEActive
Quantity: 20 mg in 1 1
Code: W31X2H97FB
Classification: ACTIB
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
Torsemide
PRODUCT DETAILS
NDC Product Code65862-128
Application NumberANDA078249
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJune 14, 2023
Generic NameTorsemide
INGREDIENTS (6)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TORSEMIDEActive
Quantity: 100 mg in 1 1
Code: W31X2H97FB
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT