FDA.reportPublic FDA data

Spironolactone

Product NDC
53746-511
11-digit product format
537460511
Labeler code
53746
Product ID
53746-511_0b757d66-e1f0-4d56-bbe0-2f0941f0a35e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Spironolactone
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals of New York LLC
Application
ANDA091426
Marketing category
ANDA
Marketing start
2010-08-02
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
2026-12-31

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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508
f151007d-265d-9fbe-857d-1d44f1cb76baProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53746-511-01Spironolactone100 in 1 BOTTLETABLET10020
53746-511-05Spironolactone500 in 1 BOTTLETABLET50020
53746-511-10Spironolactone1000 in 1 BOTTLETABLET100020
53746-511-30Spironolactone30 in 1 BOTTLETABLET3020
53746-511-60Spironolactone60 in 1 BOTTLETABLET6020
53746-511-90Spironolactone90 in 1 BOTTLETABLET9020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53746-511-01EA - Each53746-51169704d41-1e99-4986-9557-27761c6e40b912014-02-04
53746-511-05EA - Each53746-511e178305c-b546-4eb2-8bcc-574ff2d30ef212014-02-04
53746-511-10EA - Each53746-511dd2f6b49-381e-46e0-9974-33fd97efb5d112014-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SPIRONOLACTONEACTIVE INGREDIENT27O7W4T232SPIRONOLACTONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]13
SPIRONOLACTONEACTIVE MOIETY27O7W4T232SPIRONOLACTONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]13
CALCIUM SULFATEINACTIVE INGREDIENTWAT0DDB505SPIRONOLACTONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]13
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USPIRONOLACTONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]13
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48SPIRONOLACTONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]13
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GSPIRONOLACTONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]13
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8SPIRONOLACTONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]13
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675SPIRONOLACTONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]13
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTSPIRONOLACTONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]13
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357SPIRONOLACTONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]13
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSPIRONOLACTONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]13
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SPIRONOLACTONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]13
PEPPERMINTINACTIVE INGREDIENTV95R5KMY2BSPIRONOLACTONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]13
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IESPIRONOLACTONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]13
POLYETHYLENE GLYCOL 3000INACTIVE INGREDIENTSA1B764746SPIRONOLACTONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]13
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PSPIRONOLACTONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]13
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BSPIRONOLACTONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]13
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990SPIRONOLACTONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]13
POVIDONESINACTIVE INGREDIENTFZ989GH94ESPIRONOLACTONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]13
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSPIRONOLACTONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]13
TALCINACTIVE INGREDIENT7SEV7J4R1USPIRONOLACTONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]13
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSPIRONOLACTONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]13
TRIACETININACTIVE INGREDIENTXHX3C3X673SPIRONOLACTONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]13
SPIRONOLACTONEACTIVE INGREDIENT27O7W4T232SPIRONOLACTONE TABLET [BLENHEIM PHARMACAL, INC.]1
SPIRONOLACTONEACTIVE MOIETY27O7W4T232SPIRONOLACTONE TABLET [BLENHEIM PHARMACAL, INC.]1
CALCIUM SULFATEINACTIVE INGREDIENTWAT0DDB505SPIRONOLACTONE TABLET [BLENHEIM PHARMACAL, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USPIRONOLACTONE TABLET [BLENHEIM PHARMACAL, INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48SPIRONOLACTONE TABLET [BLENHEIM PHARMACAL, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSPIRONOLACTONE TABLET [BLENHEIM PHARMACAL, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SPIRONOLACTONE TABLET [BLENHEIM PHARMACAL, INC.]1
PEPPERMINTINACTIVE INGREDIENTV95R5KMY2BSPIRONOLACTONE TABLET [BLENHEIM PHARMACAL, INC.]1
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IESPIRONOLACTONE TABLET [BLENHEIM PHARMACAL, INC.]1
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BSPIRONOLACTONE TABLET [BLENHEIM PHARMACAL, INC.]1
POVIDONESINACTIVE INGREDIENTFZ989GH94ESPIRONOLACTONE TABLET [BLENHEIM PHARMACAL, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSPIRONOLACTONE TABLET [BLENHEIM PHARMACAL, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSPIRONOLACTONE TABLET [BLENHEIM PHARMACAL, INC.]1
TRIACETININACTIVE INGREDIENTXHX3C3X673SPIRONOLACTONE TABLET [BLENHEIM PHARMACAL, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53746-511SPIRONOLACTONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]19Current NDC, Legacy NDC, 6 package rows20241003_951b8948-dc0f-4aef-9910-82c252de936d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198222spironolactone 100 MG Oral TabletPSN951b8948-dc0f-4aef-9910-82c252de936d20
313096spironolactone 25 MG Oral TabletPSN951b8948-dc0f-4aef-9910-82c252de936d20
198223spironolactone 50 MG Oral TabletPSN951b8948-dc0f-4aef-9910-82c252de936d20
198222spironolactone 100 MG Oral TabletSCD951b8948-dc0f-4aef-9910-82c252de936d20
313096spironolactone 25 MG Oral TabletSCD951b8948-dc0f-4aef-9910-82c252de936d20
198223spironolactone 50 MG Oral TabletSCD951b8948-dc0f-4aef-9910-82c252de936d20
313096spironolactone 25 MG Oral TabletPSN88615d0b-ab11-092b-e053-2a95a90ac4187
313096spironolactone 25 MG Oral TabletPSNeb314e91-6dd5-4bdb-af35-5d147b20339c7
313096spironolactone 25 MG Oral TabletSCD88615d0b-ab11-092b-e053-2a95a90ac4187
313096spironolactone 25 MG Oral TabletSCDeb314e91-6dd5-4bdb-af35-5d147b20339c7
313096spironolactone 25 MG Oral TabletPSN10538860-d9ad-6cfd-e054-00144ff8d46c1
313096spironolactone 25 MG Oral TabletPSNbf58378f-8304-4799-b0c0-fad8697149ab1
313096spironolactone 25 MG Oral TabletSCD10538860-d9ad-6cfd-e054-00144ff8d46c1
313096spironolactone 25 MG Oral TabletSCDbf58378f-8304-4799-b0c0-fad8697149ab1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53746-511-0153746051101100 TABLET in 1 BOTTLE (53746-511-01) 100 tablet2010-08-020000-00-00NoNoCurrent
53746-511-0553746051105500 TABLET in 1 BOTTLE (53746-511-05) 500 tablet2010-08-020000-00-00NoNoCurrent
53746-511-10537460511101000 TABLET in 1 BOTTLE (53746-511-10) 1000 tablet2010-08-020000-00-00NoNoCurrent
53746-511-305374605113030 TABLET in 1 BOTTLE (53746-511-30) 30 tablet2010-08-020000-00-00NoNoCurrent
53746-511-605374605116060 TABLET in 1 BOTTLE (53746-511-60) 60 tablet2010-08-020000-00-00NoNoCurrent
53746-511-905374605119090 TABLET in 1 BOTTLE (53746-511-90) 90 tablet2010-08-020000-00-00NoNoCurrent