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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72603-134
Application NumberANDA202187
Product Classification
M
Marketing Category
C73584
G
Generic Name
SPIRONOLACTONE
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 27, 2023
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72603-136
Application NumberANDA202187
Product Classification
M
Marketing Category
C73584
G
Generic Name
SPIRONOLACTONE
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 27, 2023
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72603-135
Application NumberANDA202187
Product Classification
M
Marketing Category
C73584
G
Generic Name
SPIRONOLACTONE
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 27, 2023
FDA Product Classification
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