SPIRONOLACTONE

Basic Information

Product Name

SPIRONOLACTONE

FDA Product Code

53489-329

Regulatory Information

NDC Product Code

53489-329

Application Number

ANDA089424

Marketing Category

C73584

Effective Date

January 20, 2023

Territorial Authority

USA

FDA Title

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

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

ANHYDROUS LACTOSE

Code: 3SY5LH9PMK

Class Code: IACT

CARNAUBA WAX

Code: R12CBM0EIZ

Class Code: IACT

DOCUSATE SODIUM

Code: F05Q2T2JA0

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

SODIUM BENZOATE

Code: OJ245FE5EU

Class Code: IACT

HYPROMELLOSE, UNSPECIFIED

Code: 3NXW29V3WO

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

POLYDEXTROSE

Code: VH2XOU12IE

Class Code: IACT

POVIDONE, UNSPECIFIED

Code: FZ989GH94E

Class Code: IACT

POLYETHYLENE GLYCOL, UNSPECIFIED

Code: 3WJQ0SDW1A

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATO

Code: 5856J3G2A2

Class Code: IACT

TRIACETIN

Code: XHX3C3X673

Class Code: IACT

SPIRONOLACTONE

Quantity: 100 mg in 1 1

Code: 27O7W4T232

Class Code: ACTIB

Active Moieties

Code: 27O7W4T232

SPIRONOLACTONE

Basic Information

Regulatory Information

Company Information

Active Ingredients

ANHYDROUS LACTOSE

CARNAUBA WAX

DOCUSATE SODIUM

SILICON DIOXIDE

SODIUM BENZOATE

HYPROMELLOSE, UNSPECIFIED

MAGNESIUM STEARATE

MICROCRYSTALLINE CELLULOSE

POLYDEXTROSE

POVIDONE, UNSPECIFIED

POLYETHYLENE GLYCOL, UNSPECIFIED

TITANIUM DIOXIDE

SODIUM STARCH GLYCOLATE TYPE A POTATO

TRIACETIN

Active Moieties

SPIRONOLACTONE