Spironolactone
SPIRONOLACTONE TABLETS, USP
Approved
Approval ID
617aef1f-3f2c-4d33-8baf-40995b8f6a24
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 29, 2011
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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 Code54868-5015
Application NumberANDA040353
Product Classification
M
Marketing Category
C73584
G
Generic Name
Spironolactone
Product Specifications
Route of AdministrationORAL
Effective DateDecember 29, 2011
FDA Product Classification
INGREDIENTS (15)
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
SPIRONOLACTONEActive
Quantity: 100 mg in 1 1
Code: 27O7W4T232
Classification: ACTIB
CALCIUM SULFATEInactive
Code: WAT0DDB505
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
PEPPERMINTInactive
Code: V95R5KMY2B
Classification: IACT
DEXTROSEInactive
Code: IY9XDZ35W2
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
Spironolactone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-0700
Application NumberANDA040353
Product Classification
M
Marketing Category
C73584
G
Generic Name
Spironolactone
Product Specifications
Route of AdministrationORAL
Effective DateDecember 29, 2011
FDA Product Classification
INGREDIENTS (15)
SPIRONOLACTONEActive
Quantity: 25 mg in 1 1
Code: 27O7W4T232
Classification: ACTIB
CALCIUM SULFATEInactive
Code: WAT0DDB505
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
DEXTROSEInactive
Code: IY9XDZ35W2
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
PEPPERMINTInactive
Code: V95R5KMY2B
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
Spironolactone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-4477
Application NumberANDA040353
Product Classification
M
Marketing Category
C73584
G
Generic Name
Spironolactone
Product Specifications
Route of AdministrationORAL
Effective DateDecember 29, 2011
FDA Product Classification
INGREDIENTS (15)
SPIRONOLACTONEActive
Quantity: 50 mg in 1 1
Code: 27O7W4T232
Classification: ACTIB
CALCIUM SULFATEInactive
Code: WAT0DDB505
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
DEXTROSEInactive
Code: IY9XDZ35W2
Classification: IACT
PEPPERMINTInactive
Code: V95R5KMY2B
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT