Spironolactone
SPIRONOLACTONE TABLETS, USP 25 mg, 50 mg, 100 mg
Approved
Approval ID
7c850c17-9a7d-423a-86bd-ac108d1c7932
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 8, 2010
Manufacturers
FDA
State of Florida DOH Central Pharmacy
DUNS: 829348114
Products 2
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 Code53808-0592
Application NumberANDA040750
Product Classification
M
Marketing Category
C73584
G
Generic Name
spironolactone
Product Specifications
Route of AdministrationORAL
Effective DateJune 8, 2010
FDA Product Classification
INGREDIENTS (11)
SPIRONOLACTONEActive
Quantity: 25 mg in 1 1
Code: 27O7W4T232
Classification: ACTIB
CALCIUM SULFATEInactive
Code: WAT0DDB505
Classification: IACT
HYPROMELLOSEInactive
Code: 3NXW29V3WO
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
spironolactone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53808-0338
Application NumberANDA040750
Product Classification
M
Marketing Category
C73584
G
Generic Name
spironolactone
Product Specifications
Route of AdministrationORAL
Effective DateJune 8, 2010
FDA Product Classification
INGREDIENTS (11)
CALCIUM SULFATEInactive
Code: WAT0DDB505
Classification: IACT
SPIRONOLACTONEActive
Quantity: 100 mg in 1 1
Code: 27O7W4T232
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSEInactive
Code: 3NXW29V3WO
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT