FDA.reportPublic FDA data

SPIRONOLACTONE

Product NDC
53489-329
11-digit product format
534890329
Labeler code
53489
Product ID
53489-329_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
100 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
SPIRONOLACTONE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii27O7W4T232

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
53489-329-01SPIRONOLACTONE100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10014
53489-329-02SPIRONOLACTONE50 in 1 BOTTLE, PLASTICTABLET, FILM COATED5014
53489-329-03SPIRONOLACTONE250 in 1 BOTTLE, PLASTICTABLET, FILM COATED25014
53489-329-05SPIRONOLACTONE500 in 1 BOTTLE, PLASTICTABLET, FILM COATED50014
53489-329-06SPIRONOLACTONE60 in 1 BOTTLE, PLASTICTABLET, FILM COATED6014
53489-329-07SPIRONOLACTONE30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3014
53489-329-10SPIRONOLACTONE1000 in 1 BOTTLE, PLASTICTABLET, FILM COATED100014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53489-329-01EA - Each53489-3294e6dcced-ea2c-47df-b19b-8766c48fc76212012-07-24
53489-329-05EA - Each53489-3293c643ef8-0d71-4627-81fb-8495085f4a6612012-07-24
53489-329-06EA - Each53489-329e646fbb2-7b6f-4e52-9a64-516595660c8212012-07-24
53489-329-07EA - Each53489-329ed866c79-3477-45e6-a4a6-e391ffe8347112012-07-24

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
53489-329SPIRONOLACTONE 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
198222spironolactone 100 MG Oral TabletPSNb7a1f1d6-0724-4ad9-a4f9-7b1fe910f95d1011
198222spironolactone 100 MG Oral TabletSCDb7a1f1d6-0724-4ad9-a4f9-7b1fe910f95d1011
198222spironolactone 100 MG Oral TabletPSNd4cf1136-df3a-4fc2-9a21-9032949eca41107
198222spironolactone 100 MG Oral TabletSCDd4cf1136-df3a-4fc2-9a21-9032949eca41107
198222spironolactone 100 MG Oral TabletPSN1c31c953-05ce-475a-b93f-80aeb12bde95103
198222spironolactone 100 MG Oral TabletPSNbb1423e8-1517-44c5-98e0-99be24ce269b103
198222spironolactone 100 MG Oral TabletSCD1c31c953-05ce-475a-b93f-80aeb12bde95103
198222spironolactone 100 MG Oral TabletSCDbb1423e8-1517-44c5-98e0-99be24ce269b103
198222spironolactone 100 MG Oral TabletPSN1fe93db1-0012-4ff6-a4e6-04e2d7e9f63821
198222spironolactone 100 MG Oral TabletSCD1fe93db1-0012-4ff6-a4e6-04e2d7e9f63821
198222spironolactone 100 MG Oral TabletPSN4514fa40-613e-46f5-bee4-3edc7cc9863f12
198222spironolactone 100 MG Oral TabletSCD4514fa40-613e-46f5-bee4-3edc7cc9863f12
198222spironolactone 100 MG Oral TabletPSN66c46ede-4f56-436a-993b-006b4eb56fc310
198222spironolactone 100 MG Oral TabletPSN0cc23419-e6d5-4036-8011-dc1d2455e0cb10
198222spironolactone 100 MG Oral TabletSCD0cc23419-e6d5-4036-8011-dc1d2455e0cb10
198222spironolactone 100 MG Oral TabletSCD66c46ede-4f56-436a-993b-006b4eb56fc310
198222spironolactone 100 MG Oral TabletPSNf826c86a-0957-843d-e053-6394a90a5c7c1
198222spironolactone 100 MG Oral TabletPSN731894f2-bb1b-4ff6-b8c4-b8722e1731991
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
198222spironolactone 100 MG Oral TabletSCDf826c86a-0957-843d-e053-6394a90a5c7c1
313096spironolactone 25 MG Oral TabletSCD731894f2-bb1b-4ff6-b8c4-b8722e1731991
198223spironolactone 50 MG Oral TabletSCD731894f2-bb1b-4ff6-b8c4-b8722e1731991

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53489-329-0153489032901100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-329-01) 1986-07-230000-00-00NoNoCurrent
53489-329-025348903290250 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-329-02) 1986-07-230000-00-00NoNoCurrent
53489-329-0353489032903250 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-329-03) 1986-07-230000-00-00NoNoCurrent
53489-329-0553489032905500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-329-05) 1986-07-230000-00-00NoNoCurrent
53489-329-065348903290660 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-329-06) 1986-07-230000-00-00NoNoCurrent
53489-329-075348903290730 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-329-07) 1986-07-230000-00-00NoNoCurrent
53489-329-10534890329101000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-329-10) 1986-07-230000-00-00NoNoCurrent