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
a7510768-8a52-4230-6aa0-b0d92d82588f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 3, 2023
Manufacturers
FDA
Jubilant Cadista Pharmaceuticals Inc.
DUNS: 022490515
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 Code59746-217
Application NumberANDA203253
Product Classification
M
Marketing Category
C73584
G
Generic Name
spironolactone
Product Specifications
Route of AdministrationORAL
Effective DateApril 3, 2023
FDA Product Classification
INGREDIENTS (12)
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
spironolactoneActive
Quantity: 50 mg in 1 1
Code: 27O7W4T232
Classification: ACTIB
calcium sulfateInactive
Code: WAT0DDB505
Classification: IACT
HypromellosesInactive
Code: 3NXW29V3WO
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
Povidone, UnspecifiedInactive
Code: FZ989GH94E
Classification: IACT
Ferric Oxide RedInactive
Code: 1K09F3G675
Classification: IACT
PeppermintInactive
Code: V95R5KMY2B
Classification: IACT
Ferric Oxide YellowInactive
Code: EX438O2MRT
Classification: IACT
Ferrosoferric OxideInactive
Code: XM0M87F357
Classification: IACT
Polyethylene Glycol, UnspecifiedInactive
Code: 3WJQ0SDW1A
Classification: IACT
spironolactone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59746-216
Application NumberANDA203253
Product Classification
M
Marketing Category
C73584
G
Generic Name
spironolactone
Product Specifications
Route of AdministrationORAL
Effective DateApril 3, 2023
FDA Product Classification
INGREDIENTS (12)
spironolactoneActive
Quantity: 25 mg in 1 1
Code: 27O7W4T232
Classification: ACTIB
Calcium Sulfate DihydrateInactive
Code: 4846Q921YM
Classification: IACT
HypromellosesInactive
Code: 3NXW29V3WO
Classification: IACT
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
Povidone, UnspecifiedInactive
Code: FZ989GH94E
Classification: IACT
PeppermintInactive
Code: V95R5KMY2B
Classification: IACT
Ferric Oxide RedInactive
Code: 1K09F3G675
Classification: IACT
Ferrosoferric OxideInactive
Code: XM0M87F357
Classification: IACT
Ferric Oxide YellowInactive
Code: EX438O2MRT
Classification: IACT
Polyethylene Glycol, UnspecifiedInactive
Code: 3WJQ0SDW1A
Classification: IACT
spironolactone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59746-218
Application NumberANDA203253
Product Classification
M
Marketing Category
C73584
G
Generic Name
spironolactone
Product Specifications
Route of AdministrationORAL
Effective DateApril 3, 2023
FDA Product Classification
INGREDIENTS (12)
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
Povidone, UnspecifiedInactive
Code: FZ989GH94E
Classification: IACT
Ferric Oxide YellowInactive
Code: EX438O2MRT
Classification: IACT
HypromellosesInactive
Code: 3NXW29V3WO
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
spironolactoneActive
Quantity: 100 mg in 1 1
Code: 27O7W4T232
Classification: ACTIB
calcium sulfateInactive
Code: WAT0DDB505
Classification: IACT
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
Ferric Oxide RedInactive
Code: 1K09F3G675
Classification: IACT
Ferrosoferric OxideInactive
Code: XM0M87F357
Classification: IACT
Polyethylene Glycol, UnspecifiedInactive
Code: 3WJQ0SDW1A
Classification: IACT
PeppermintInactive
Code: V95R5KMY2B
Classification: IACT