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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 useInitial U.S. Approval: 1993

Approved
Approval ID

8a95cbdb-0601-47a5-9b3a-0c3b0629ceb9

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Feb 28, 2017

Manufacturers
FDA

Teva Pharmaceuticals USA, Inc.

DUNS: 001627975

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 Code50111-916
Application NumberANDA076346
Product Classification
M
Marketing Category
C73584
G
Generic Name
Torsemide
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 28, 2017
FDA Product Classification

INGREDIENTS (6)

TORSEMIDEActive
Quantity: 10 mg in 1 1
Code: W31X2H97FB
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT

Torsemide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code50111-915
Application NumberANDA076346
Product Classification
M
Marketing Category
C73584
G
Generic Name
Torsemide
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 28, 2017
FDA Product Classification

INGREDIENTS (6)

TORSEMIDEActive
Quantity: 5 mg in 1 1
Code: W31X2H97FB
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT

Torsemide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code50111-917
Application NumberANDA076346
Product Classification
M
Marketing Category
C73584
G
Generic Name
Torsemide
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 28, 2017
FDA Product Classification

INGREDIENTS (6)

SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TORSEMIDEActive
Quantity: 20 mg in 1 1
Code: W31X2H97FB
Classification: ACTIB
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT

Torsemide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code50111-918
Application NumberANDA076346
Product Classification
M
Marketing Category
C73584
G
Generic Name
Torsemide
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 28, 2017
FDA Product Classification

INGREDIENTS (6)

SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TORSEMIDEActive
Quantity: 100 mg in 1 1
Code: W31X2H97FB
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT

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