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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

0d4a4ef9-0944-452c-b014-bd822bfb9dd9

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Aug 14, 2017

Manufacturers
FDA

Camber Pharmaceuticals, Inc.

DUNS: 826774775

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 Code31722-532
Application NumberANDA079234
Product Classification
M
Marketing Category
C73584
G
Generic Name
Torsemide
Product Specifications
Route of AdministrationORAL
Effective DateAugust 18, 2017
FDA Product Classification

INGREDIENTS (6)

TORSEMIDEActive
Quantity: 100 mg in 1 1
Code: W31X2H97FB
Classification: ACTIB
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT

Torsemide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code31722-529
Application NumberANDA079234
Product Classification
M
Marketing Category
C73584
G
Generic Name
Torsemide
Product Specifications
Route of AdministrationORAL
Effective DateAugust 18, 2017
FDA Product Classification

INGREDIENTS (6)

TORSEMIDEActive
Quantity: 5 mg in 1 1
Code: W31X2H97FB
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT

Torsemide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code31722-531
Application NumberANDA079234
Product Classification
M
Marketing Category
C73584
G
Generic Name
Torsemide
Product Specifications
Route of AdministrationORAL
Effective DateAugust 18, 2017
FDA Product Classification

INGREDIENTS (6)

TORSEMIDEActive
Quantity: 20 mg in 1 1
Code: W31X2H97FB
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT

Torsemide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code31722-530
Application NumberANDA079234
Product Classification
M
Marketing Category
C73584
G
Generic Name
Torsemide
Product Specifications
Route of AdministrationORAL
Effective DateAugust 18, 2017
FDA Product Classification

INGREDIENTS (6)

TORSEMIDEActive
Quantity: 10 mg in 1 1
Code: W31X2H97FB
Classification: ACTIB
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT

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Torsemide - FDA Drug Approval Details