FDA.reportPublic FDA data

SPIRONOLACTONE

Product NDC
53489-328
11-digit product format
534890328
Labeler code
53489
Product ID
53489-328_d58f76e0-60c3-42ec-8375-128cd42485f1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SPIRONOLACTONE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA089424
Marketing category
ANDA
Marketing start
1986-07-23
Substance
SPIRONOLACTONE
Active strength
50 mg/1
Pharmacologic classes
Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
SPIRONOLACTONE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SPIRONOLACTONE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii27O7W4T232
Rxcui198222, 198223, 313096

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d335cba1-5b36-51c8-120a-594ec9d05330Product name520251114
25f5e2cf-3572-477b-994c-aa692751e5a8Product name220250616
f151007d-265d-9fbe-857d-1d44f1cb76baProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53489-328-01SPIRONOLACTONE100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10014
53489-328-02SPIRONOLACTONE50 in 1 BOTTLE, PLASTICTABLET, FILM COATED5014
53489-328-03SPIRONOLACTONE250 in 1 BOTTLE, PLASTICTABLET, FILM COATED25014
53489-328-05SPIRONOLACTONE500 in 1 BOTTLE, PLASTICTABLET, FILM COATED50014
53489-328-06SPIRONOLACTONE60 in 1 BOTTLE, PLASTICTABLET, FILM COATED6014
53489-328-07SPIRONOLACTONE30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3014
53489-328-10SPIRONOLACTONE1000 in 1 BOTTLE, PLASTICTABLET, FILM COATED100014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53489-328-01EA - Each53489-328a105f7c9-2713-4452-ab0f-f7348a0cfc0212012-07-24
53489-328-05EA - Each53489-328e7fc6941-dbf4-4473-ad27-a9ec1de13ca212012-07-24
53489-328-06EA - Each53489-32862edf34f-957c-419e-92e9-c521d7cf6c2712012-07-24
53489-328-07EA - Each53489-32887115496-ccc6-4999-8736-3457c32661b312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SPIRONOLACTONEACTIVE INGREDIENT27O7W4T232SPIRONOLACTONE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
SPIRONOLACTONEACTIVE MOIETY27O7W4T232SPIRONOLACTONE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKSPIRONOLACTONE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZSPIRONOLACTONE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USPIRONOLACTONE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0SPIRONOLACTONE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSPIRONOLACTONE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SPIRONOLACTONE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IESPIRONOLACTONE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ASPIRONOLACTONE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
POVIDONESINACTIVE INGREDIENTFZ989GH94ESPIRONOLACTONE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4SPIRONOLACTONE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUSPIRONOLACTONE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2SPIRONOLACTONE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSPIRONOLACTONE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
TRIACETININACTIVE INGREDIENTXHX3C3X673SPIRONOLACTONE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
SpironolactoneACTIVE INGREDIENT27O7W4T232SPIRONOLACTONE TABLET SPIRONOLACTONE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.]7
SpironolactoneACTIVE MOIETY27O7W4T232SPIRONOLACTONE TABLET SPIRONOLACTONE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.]7
anhydrous lactoseINACTIVE INGREDIENT3SY5LH9PMKSPIRONOLACTONE TABLET SPIRONOLACTONE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.]7
carnauba waxINACTIVE INGREDIENTR12CBM0EIZSPIRONOLACTONE TABLET SPIRONOLACTONE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.]7
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61USPIRONOLACTONE TABLET SPIRONOLACTONE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.]7
crospovidoneINACTIVE INGREDIENT68401960MKSPIRONOLACTONE TABLET SPIRONOLACTONE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.]7
docusate sodiumINACTIVE INGREDIENTF05Q2T2JA0SPIRONOLACTONE TABLET SPIRONOLACTONE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.]7
hypromellosesINACTIVE INGREDIENT3NXW29V3WOSPIRONOLACTONE TABLET SPIRONOLACTONE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.]7
magnesium stearateINACTIVE INGREDIENT70097M6I30SPIRONOLACTONE TABLET SPIRONOLACTONE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.]7
polydextroseINACTIVE INGREDIENTVH2XOU12IESPIRONOLACTONE TABLET SPIRONOLACTONE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.]7
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1ASPIRONOLACTONE TABLET SPIRONOLACTONE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.]7
povidonesINACTIVE INGREDIENTFZ989GH94ESPIRONOLACTONE TABLET SPIRONOLACTONE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.]7
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4SPIRONOLACTONE TABLET SPIRONOLACTONE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.]7
sodium benzoateINACTIVE INGREDIENTOJ245FE5EUSPIRONOLACTONE TABLET SPIRONOLACTONE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.]7
sodium starch glycolate type a potatoINACTIVE INGREDIENT5856J3G2A2SPIRONOLACTONE TABLET SPIRONOLACTONE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.]7
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPSPIRONOLACTONE TABLET SPIRONOLACTONE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.]7
triacetinINACTIVE INGREDIENTXHX3C3X673SPIRONOLACTONE TABLET SPIRONOLACTONE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53489-328SPIRONOLACTONE TABLET SPIRONOLACTONE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]13Current NDC, Legacy NDC, 7 package rows20230126_c23b6b9b-aec3-48a8-a518-76e4097f6479.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198223spironolactone 50 MG Oral TabletPSNcae68fd6-5161-4650-bcde-6db98cbe6c8b1015
198223spironolactone 50 MG Oral TabletSCDcae68fd6-5161-4650-bcde-6db98cbe6c8b1015
198223spironolactone 50 MG Oral TabletPSN3b60de71-2afa-4922-ba3e-0664c2ae29a0109
198223spironolactone 50 MG Oral TabletSCD3b60de71-2afa-4922-ba3e-0664c2ae29a0109
198223spironolactone 50 MG Oral TabletPSNcbc817de-5ea8-4139-9c13-02bac8ff93c3104
198223spironolactone 50 MG Oral TabletSCDcbc817de-5ea8-4139-9c13-02bac8ff93c3104
198223spironolactone 50 MG Oral TabletPSN813d199a-9004-4102-8ade-cf877caedafb101
198223spironolactone 50 MG Oral TabletSCD813d199a-9004-4102-8ade-cf877caedafb101
198223spironolactone 50 MG Oral TabletPSNbe4aa233-1555-4972-858e-46343a710558100
198223spironolactone 50 MG Oral TabletSCDbe4aa233-1555-4972-858e-46343a710558100
198223spironolactone 50 MG Oral TabletPSNa6e0bf0e-42d3-41e4-854b-811df3bbaaa912
198223spironolactone 50 MG Oral TabletSCDa6e0bf0e-42d3-41e4-854b-811df3bbaaa912
198223spironolactone 50 MG Oral TabletPSNcaf41e17-0461-4667-9eab-62853b94513110
198223spironolactone 50 MG Oral TabletSCDcaf41e17-0461-4667-9eab-62853b94513110
198223spironolactone 50 MG Oral TabletPSNbe568fbd-3c3d-417c-ae96-75a78ca4b7cd3
198223spironolactone 50 MG Oral TabletSCDbe568fbd-3c3d-417c-ae96-75a78ca4b7cd3
198222spironolactone 100 MG Oral TabletPSN731894f2-bb1b-4ff6-b8c4-b8722e1731991
313096spironolactone 25 MG Oral TabletPSN731894f2-bb1b-4ff6-b8c4-b8722e1731991
198223spironolactone 50 MG Oral TabletPSN416ce231-fc8d-4ba0-a1ce-d5e054cf025e1
198223spironolactone 50 MG Oral TabletPSN731894f2-bb1b-4ff6-b8c4-b8722e1731991
198222spironolactone 100 MG Oral TabletSCD731894f2-bb1b-4ff6-b8c4-b8722e1731991
313096spironolactone 25 MG Oral TabletSCD731894f2-bb1b-4ff6-b8c4-b8722e1731991
198223spironolactone 50 MG Oral TabletSCD416ce231-fc8d-4ba0-a1ce-d5e054cf025e1
198223spironolactone 50 MG Oral TabletSCD731894f2-bb1b-4ff6-b8c4-b8722e1731991

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53489-328-0153489032801100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-328-01) 1986-07-230000-00-00NoNoCurrent
53489-328-025348903280250 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-328-02) 1986-07-230000-00-00NoNoCurrent
53489-328-0353489032803250 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-328-03) 1986-07-230000-00-00NoNoCurrent
53489-328-0553489032805500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-328-05) 1986-07-230000-00-00NoNoCurrent
53489-328-065348903280660 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-328-06) 1986-07-230000-00-00NoNoCurrent
53489-328-075348903280730 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-328-07) 1986-07-230000-00-00NoNoCurrent
53489-328-10534890328101000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-328-10) 1986-07-230000-00-00NoNoCurrent