Spironolactone
These highlights do not include all the information needed to use SPIRONOLACTONE TABLETS safely and effectively. See full prescribing information for SPIRONOLACTONE TABLETS. tablets for oral use Initial U.S. Approval: 1960
Approved
Approval ID
8f0291a9-c8a6-4298-a540-23abc01fae09
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 26, 2024
Manufacturers
FDA
REMEDYREPACK INC.
DUNS: 829572556
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Spironolactone
PRODUCT DETAILS
NDC Product Code70518-3625
Application NumberANDA040750
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateMarch 26, 2024
Generic NameSpironolactone
INGREDIENTS (13)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CALCIUM SULFATE DIHYDRATEInactive
Code: 4846Q921YM
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MINTInactive
Code: FV98Z8GITP
Classification: IACT
MICROCRYSTALLINE CELLULOSE 101Inactive
Code: 7T9FYH5QMK
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
SPIRONOLACTONEActive
Quantity: 25 mg in 1 1
Code: 27O7W4T232
Classification: ACTIB
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT