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SPIRONOLACTONE

These highlights do not include all the information needed to use SPIRONOLACTONE TABLETS safely and effectively. See full prescribing information for SPIRONOLACTONE TABLETS. SPIRONOLACTONE tablets for oral use Initial U.S. Approval: 1960

Approved
Approval ID

ae0dcb4e-63df-459c-8e60-0caa817b8135

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 27, 2023

Manufacturers
FDA

NorthStar Rx LLC

DUNS: 830546433

Products 3

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

SPIRONOLACTONE

PRODUCT DETAILS

NDC Product Code72603-134
Application NumberANDA202187
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 27, 2023
Generic NameSPIRONOLACTONE

INGREDIENTS (8)

POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
POVIDONE K25Inactive
Code: K0KQV10C35
Classification: IACT
SPIRONOLACTONEActive
Quantity: 25 mg in 1 1
Code: 27O7W4T232
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
PEPPERMINT OILInactive
Code: AV092KU4JH
Classification: IACT

SPIRONOLACTONE

PRODUCT DETAILS

NDC Product Code72603-136
Application NumberANDA202187
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 27, 2023
Generic NameSPIRONOLACTONE

INGREDIENTS (8)

STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SPIRONOLACTONEActive
Quantity: 100 mg in 1 1
Code: 27O7W4T232
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
PEPPERMINT OILInactive
Code: AV092KU4JH
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
POVIDONE K25Inactive
Code: K0KQV10C35
Classification: IACT

SPIRONOLACTONE

PRODUCT DETAILS

NDC Product Code72603-135
Application NumberANDA202187
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 27, 2023
Generic NameSPIRONOLACTONE

INGREDIENTS (8)

SPIRONOLACTONEActive
Quantity: 50 mg in 1 1
Code: 27O7W4T232
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
PEPPERMINT OILInactive
Code: AV092KU4JH
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
POVIDONE K25Inactive
Code: K0KQV10C35
Classification: IACT
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SPIRONOLACTONE - FDA Approval | MedPath