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
c450e66a-0f05-445e-b1df-df2b17a2f064
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 14, 2022
Manufacturers
FDA
PharmPak, Inc.
DUNS: 175493840
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 Code54348-340
Application NumberANDA091426
Product Classification
M
Marketing Category
C73584
G
Generic Name
SPIRONOLACTONE
Product Specifications
Route of AdministrationORAL
Effective DateOctober 14, 2022
FDA Product Classification
INGREDIENTS (13)
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
SPIRONOLACTONEActive
Quantity: 50 mg in 1 1
Code: 27O7W4T232
Classification: ACTIB
CALCIUM SULFATE DIHYDRATEInactive
Code: 4846Q921YM
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
PEPPERMINTInactive
Code: V95R5KMY2B
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT