FDA.reportPublic FDA data

SPIRONOLACTONE

Product NDC
53489-143
11-digit product format
534890143
Labeler code
53489
Product ID
53489-143_d58f76e0-60c3-42ec-8375-128cd42485f1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SPIRONOLACTONE
Dosage form
TABLET
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA089424
Marketing category
ANDA
Marketing start
1986-07-23
Substance
SPIRONOLACTONE
Active strength
25 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
SPIRONOLACTONE25 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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
f151007d-265d-9fbe-857d-1d44f1cb76baProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53489-143-01SPIRONOLACTONE100 in 1 BOTTLE, PLASTICTABLET10014
53489-143-05SPIRONOLACTONE500 in 1 BOTTLE, PLASTICTABLET50014
53489-143-10SPIRONOLACTONE1000 in 1 BOTTLE, PLASTICTABLET100014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53489-143-01EA - Each53489-1434b81a26b-799c-45b9-801e-89b98c890c6a12012-07-24
53489-143-05EA - Each53489-1435fcaa8df-c45d-4cec-a27a-d11a9e42086b12012-07-24
53489-143-10EA - Each53489-14319321ea7-9c7e-4873-b1db-741b18c4640512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
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
SPIRONOLACTONEACTIVE INGREDIENT27O7W4T232SPIRONOLACTONE TABLET [BRYANT RANCH PREPACK]3
SPIRONOLACTONEACTIVE MOIETY27O7W4T232SPIRONOLACTONE TABLET [BRYANT RANCH PREPACK]3
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKSPIRONOLACTONE TABLET [BRYANT RANCH PREPACK]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USPIRONOLACTONE TABLET [BRYANT RANCH PREPACK]3
CROSPOVIDONEINACTIVE INGREDIENT68401960MKSPIRONOLACTONE TABLET [BRYANT RANCH PREPACK]3
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0SPIRONOLACTONE TABLET [BRYANT RANCH PREPACK]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SPIRONOLACTONE TABLET [BRYANT RANCH PREPACK]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4SPIRONOLACTONE TABLET [BRYANT RANCH PREPACK]3
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUSPIRONOLACTONE TABLET [BRYANT RANCH PREPACK]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2SPIRONOLACTONE TABLET [BRYANT RANCH PREPACK]3
SpironolactoneACTIVE INGREDIENT27O7W4T232SPIRONOLACTONE TABLET [REBEL DISTRIBUTORS CORP]1
SpironolactoneACTIVE INGREDIENT27O7W4T232SPIRONOLACTONE TABLET [A-S MEDICATION SOLUTIONS LLC]1
SpironolactoneACTIVE MOIETY27O7W4T232SPIRONOLACTONE TABLET [A-S MEDICATION SOLUTIONS LLC]1
SpironolactoneACTIVE MOIETY27O7W4T232SPIRONOLACTONE TABLET [REBEL DISTRIBUTORS CORP]1
anhydrous lactoseINACTIVE INGREDIENT3SY5LH9PMKSPIRONOLACTONE TABLET [A-S MEDICATION SOLUTIONS LLC]1
anhydrous lactoseINACTIVE INGREDIENT3SY5LH9PMKSPIRONOLACTONE TABLET [REBEL DISTRIBUTORS CORP]1
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61USPIRONOLACTONE TABLET [REBEL DISTRIBUTORS CORP]1
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61USPIRONOLACTONE TABLET [A-S MEDICATION SOLUTIONS LLC]1
crospovidoneINACTIVE INGREDIENT68401960MKSPIRONOLACTONE TABLET [REBEL DISTRIBUTORS CORP]1
crospovidoneINACTIVE INGREDIENT68401960MKSPIRONOLACTONE TABLET [A-S MEDICATION SOLUTIONS LLC]1
docusate sodiumINACTIVE INGREDIENTF05Q2T2JA0SPIRONOLACTONE TABLET [REBEL DISTRIBUTORS CORP]1
docusate sodiumINACTIVE INGREDIENTF05Q2T2JA0SPIRONOLACTONE TABLET [A-S MEDICATION SOLUTIONS LLC]1
magnesium stearateINACTIVE INGREDIENT70097M6I30SPIRONOLACTONE TABLET [REBEL DISTRIBUTORS CORP]1
magnesium stearateINACTIVE INGREDIENT70097M6I30SPIRONOLACTONE TABLET [A-S MEDICATION SOLUTIONS LLC]1
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4SPIRONOLACTONE TABLET [REBEL DISTRIBUTORS CORP]1
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4SPIRONOLACTONE TABLET [A-S MEDICATION SOLUTIONS LLC]1
sodium benzoateINACTIVE INGREDIENTOJ245FE5EUSPIRONOLACTONE TABLET [REBEL DISTRIBUTORS CORP]1
sodium benzoateINACTIVE INGREDIENTOJ245FE5EUSPIRONOLACTONE TABLET [A-S MEDICATION SOLUTIONS LLC]1
sodium starch glycolate type a potatoINACTIVE INGREDIENT5856J3G2A2SPIRONOLACTONE TABLET [REBEL DISTRIBUTORS CORP]1
sodium starch glycolate type a potatoINACTIVE INGREDIENT5856J3G2A2SPIRONOLACTONE TABLET [A-S MEDICATION SOLUTIONS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53489-143SPIRONOLACTONE TABLET SPIRONOLACTONE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]13Current NDC, Legacy NDC, 3 package rows20230126_c23b6b9b-aec3-48a8-a518-76e4097f6479.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313096spironolactone 25 MG Oral TabletPSN753bbc6f-2e50-49c1-b5bf-18f8411a1e8e109
313096spironolactone 25 MG Oral TabletPSN3791d79c-d960-4790-b689-ea32ddf7226a109
313096spironolactone 25 MG Oral TabletSCD753bbc6f-2e50-49c1-b5bf-18f8411a1e8e109
313096spironolactone 25 MG Oral TabletSCD3791d79c-d960-4790-b689-ea32ddf7226a109
313096spironolactone 25 MG Oral TabletPSN11d06acd-1351-4afd-a16a-f035758e2a27102
313096spironolactone 25 MG Oral TabletSCD11d06acd-1351-4afd-a16a-f035758e2a27102
313096spironolactone 25 MG Oral TabletPSN10a5c989-66e3-494d-bfd8-b2d6df3be411101
313096spironolactone 25 MG Oral TabletPSNca194a2a-ed16-40f6-a78c-45c5f3392170101
313096spironolactone 25 MG Oral TabletPSN2d0655d7-fda6-40c6-907c-acaba0e19987101
313096spironolactone 25 MG Oral TabletSCD10a5c989-66e3-494d-bfd8-b2d6df3be411101
313096spironolactone 25 MG Oral TabletSCDca194a2a-ed16-40f6-a78c-45c5f3392170101
313096spironolactone 25 MG Oral TabletSCD2d0655d7-fda6-40c6-907c-acaba0e19987101
313096spironolactone 25 MG Oral TabletPSNebc4efec-7895-4298-8e75-360bb7992f8d100
313096spironolactone 25 MG Oral TabletSCDebc4efec-7895-4298-8e75-360bb7992f8d100
313096spironolactone 25 MG Oral TabletPSNb98b7780-e310-493a-83bd-bb3d93cf8dde15
313096spironolactone 25 MG Oral TabletSCDb98b7780-e310-493a-83bd-bb3d93cf8dde15
313096spironolactone 25 MG Oral TabletPSN2efb4720-625f-6616-b6f0-8b13a17c9d7e14
313096spironolactone 25 MG Oral TabletSCD2efb4720-625f-6616-b6f0-8b13a17c9d7e14
313096spironolactone 25 MG Oral TabletPSN200b2a6a-f263-463e-a2e1-f4f74058a92411
313096spironolactone 25 MG Oral TabletSCD200b2a6a-f263-463e-a2e1-f4f74058a92411
313096spironolactone 25 MG Oral TabletPSN1b29888c-09f9-4cd5-9b4c-920bd159a72710
313096spironolactone 25 MG Oral TabletPSNd6138536-cdc1-4459-84ff-9dedc0de110510
313096spironolactone 25 MG Oral TabletSCD1b29888c-09f9-4cd5-9b4c-920bd159a72710
313096spironolactone 25 MG Oral TabletSCDd6138536-cdc1-4459-84ff-9dedc0de110510
313096spironolactone 25 MG Oral TabletPSN57f0b194-0c79-434a-9193-1b2b6b3ceeb12
313096spironolactone 25 MG Oral TabletPSN18f11eed-9ef6-43f6-8db0-720c275638712
313096spironolactone 25 MG Oral TabletSCD57f0b194-0c79-434a-9193-1b2b6b3ceeb12
313096spironolactone 25 MG Oral TabletSCD18f11eed-9ef6-43f6-8db0-720c275638712
198222spironolactone 100 MG Oral TabletPSN731894f2-bb1b-4ff6-b8c4-b8722e1731991
313096spironolactone 25 MG Oral TabletPSN90668e5a-0c0d-4941-94cf-8b2fba410ed71
313096spironolactone 25 MG Oral TabletPSN731894f2-bb1b-4ff6-b8c4-b8722e1731991
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
313096spironolactone 25 MG Oral TabletSCD90668e5a-0c0d-4941-94cf-8b2fba410ed71
198223spironolactone 50 MG Oral TabletSCD731894f2-bb1b-4ff6-b8c4-b8722e1731991

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53489-143-0153489014301100 TABLET in 1 BOTTLE, PLASTIC (53489-143-01) 100 tablet1986-07-230000-00-00NoNoCurrent
53489-143-0553489014305500 TABLET in 1 BOTTLE, PLASTIC (53489-143-05) 500 tablet1986-07-230000-00-00NoNoCurrent
53489-143-10534890143101000 TABLET in 1 BOTTLE, PLASTIC (53489-143-10) 1000 tablet1996-07-230000-00-00NoNoCurrent