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
416ce231-fc8d-4ba0-a1ce-d5e054cf025e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 1, 2023
Manufacturers
FDA
Proficient Rx LP
DUNS: 079196022
Products 1
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 Code71205-830
Application NumberANDA089424
Product Classification
M
Marketing Category
C73584
G
Generic Name
SPIRONOLACTONE
Product Specifications
Route of AdministrationORAL
Effective DateAugust 1, 2023
FDA Product Classification
INGREDIENTS (15)
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
DOCUSATE SODIUMInactive
Code: F05Q2T2JA0
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
SPIRONOLACTONEActive
Quantity: 50 mg in 1 1
Code: 27O7W4T232
Classification: ACTIB