FDA.reportPublic FDA data

Spironolactone

Product NDC
65162-511
11-digit product format
651620511
Labeler code
65162
Product ID
65162-511_8cdb3181-3666-48aa-a197-fb3a1e082e74
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Spironolactone
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals 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
f151007d-265d-9fbe-857d-1d44f1cb76baProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65162-511-03Spironolactone30 in 1 BOTTLETABLET3013
65162-511-06Spironolactone60 in 1 BOTTLETABLET6013
65162-511-09Spironolactone90 in 1 BOTTLETABLET9013
65162-511-10Spironolactone100 in 1 BOTTLETABLET10013
65162-511-11Spironolactone1000 in 1 BOTTLETABLET100013
65162-511-50Spironolactone500 in 1 BOTTLETABLET50013
65162-511-60Spironolactone100 in 1 BLISTER PACKTABLET10013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65162-511-10EA - Each65162-511b7cc97bb-c90f-4c1d-9afd-73182e32d34312012-07-24
65162-511-11EA - Each65162-51137f045cd-52e1-4c44-a9b0-aceb9a66fd1e12012-07-24
65162-511-50EA - Each65162-51151fa3768-0fa4-4338-af4e-d83ae05579af12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SPIRONOLACTONEACTIVE INGREDIENT27O7W4T232SPIRONOLACTONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]7
SPIRONOLACTONEACTIVE MOIETY27O7W4T232SPIRONOLACTONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]7
CALCIUM SULFATEINACTIVE INGREDIENTWAT0DDB505SPIRONOLACTONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USPIRONOLACTONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]7
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48SPIRONOLACTONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]7
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GSPIRONOLACTONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]7
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8SPIRONOLACTONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]7
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675SPIRONOLACTONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]7
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTSPIRONOLACTONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]7
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357SPIRONOLACTONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]7
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSPIRONOLACTONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SPIRONOLACTONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]7
PEPPERMINTINACTIVE INGREDIENTV95R5KMY2BSPIRONOLACTONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]7
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IESPIRONOLACTONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]7
POLYETHYLENE GLYCOL 3000INACTIVE INGREDIENTSA1B764746SPIRONOLACTONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]7
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PSPIRONOLACTONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]7
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BSPIRONOLACTONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]7
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990SPIRONOLACTONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]7
POVIDONESINACTIVE INGREDIENTFZ989GH94ESPIRONOLACTONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]7
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSPIRONOLACTONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]7
TALCINACTIVE INGREDIENT7SEV7J4R1USPIRONOLACTONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSPIRONOLACTONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]7
TRIACETININACTIVE INGREDIENTXHX3C3X673SPIRONOLACTONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]7
SPIRONOLACTONEACTIVE INGREDIENT27O7W4T232SPIRONOLACTONE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
SPIRONOLACTONEACTIVE INGREDIENT27O7W4T232SPIRONOLACTONE TABLET [BLENHEIM PHARMACAL, INC.]2
SPIRONOLACTONEACTIVE MOIETY27O7W4T232SPIRONOLACTONE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
SPIRONOLACTONEACTIVE MOIETY27O7W4T232SPIRONOLACTONE TABLET [BLENHEIM PHARMACAL, INC.]2
CALCIUM SULFATEINACTIVE INGREDIENTWAT0DDB505SPIRONOLACTONE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
CALCIUM SULFATEINACTIVE INGREDIENTWAT0DDB505SPIRONOLACTONE TABLET [BLENHEIM PHARMACAL, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USPIRONOLACTONE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USPIRONOLACTONE TABLET [BLENHEIM PHARMACAL, INC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48SPIRONOLACTONE TABLET [BLENHEIM PHARMACAL, INC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48SPIRONOLACTONE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSPIRONOLACTONE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSPIRONOLACTONE TABLET [BLENHEIM PHARMACAL, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SPIRONOLACTONE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SPIRONOLACTONE TABLET [BLENHEIM PHARMACAL, INC.]2
PEPPERMINTINACTIVE INGREDIENTV95R5KMY2BSPIRONOLACTONE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
PEPPERMINTINACTIVE INGREDIENTV95R5KMY2BSPIRONOLACTONE TABLET [BLENHEIM PHARMACAL, INC.]2
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IESPIRONOLACTONE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IESPIRONOLACTONE TABLET [BLENHEIM PHARMACAL, INC.]2
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BSPIRONOLACTONE TABLET [BLENHEIM PHARMACAL, INC.]2
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BSPIRONOLACTONE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
POVIDONESINACTIVE INGREDIENTFZ989GH94ESPIRONOLACTONE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
POVIDONESINACTIVE INGREDIENTFZ989GH94ESPIRONOLACTONE TABLET [BLENHEIM PHARMACAL, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSPIRONOLACTONE TABLET [BLENHEIM PHARMACAL, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSPIRONOLACTONE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSPIRONOLACTONE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSPIRONOLACTONE TABLET [BLENHEIM PHARMACAL, INC.]2
TRIACETININACTIVE INGREDIENTXHX3C3X673SPIRONOLACTONE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
TRIACETININACTIVE INGREDIENTXHX3C3X673SPIRONOLACTONE TABLET [BLENHEIM PHARMACAL, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-511SPIRONOLACTONE TABLET [AMNEAL PHARMACEUTICALS LLC]13Current NDC, Legacy NDC, 7 package rows20241031_fb66327e-8261-46ae-b39a-4fa79d520844.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198222spironolactone 100 MG Oral TabletPSNfb66327e-8261-46ae-b39a-4fa79d52084413
313096spironolactone 25 MG Oral TabletPSNfb66327e-8261-46ae-b39a-4fa79d52084413
198223spironolactone 50 MG Oral TabletPSNfb66327e-8261-46ae-b39a-4fa79d52084413
198222spironolactone 100 MG Oral TabletSCDfb66327e-8261-46ae-b39a-4fa79d52084413
313096spironolactone 25 MG Oral TabletSCDfb66327e-8261-46ae-b39a-4fa79d52084413
198223spironolactone 50 MG Oral TabletSCDfb66327e-8261-46ae-b39a-4fa79d52084413
313096spironolactone 25 MG Oral TabletPSN0ef98e7e-88c4-05c6-e054-00144ff8d46c2
313096spironolactone 25 MG Oral TabletPSN8af3eeb4-e58d-42b3-806f-625923a36b672
313096spironolactone 25 MG Oral TabletSCD0ef98e7e-88c4-05c6-e054-00144ff8d46c2
313096spironolactone 25 MG Oral TabletSCD8af3eeb4-e58d-42b3-806f-625923a36b672
313096spironolactone 25 MG Oral TabletPSN593f997d-f45c-24ec-e053-2991aa0a47161
313096spironolactone 25 MG Oral TabletSCD593f997d-f45c-24ec-e053-2991aa0a47161

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65162-511-036516205110330 TABLET in 1 BOTTLE (65162-511-03) 30 tablet2010-08-020000-00-00NoNoCurrent
65162-511-066516205110660 TABLET in 1 BOTTLE (65162-511-06) 60 tablet2010-08-020000-00-00NoNoCurrent
65162-511-096516205110990 TABLET in 1 BOTTLE (65162-511-09) 90 tablet2010-08-020000-00-00NoNoCurrent
65162-511-1065162051110100 TABLET in 1 BOTTLE (65162-511-10) 100 tablet2010-08-020000-00-00NoNoCurrent
65162-511-11651620511111000 TABLET in 1 BOTTLE (65162-511-11) 1000 tablet2010-08-020000-00-00NoNoCurrent
65162-511-5065162051150500 TABLET in 1 BOTTLE (65162-511-50) 500 tablet2010-08-020000-00-00NoNoCurrent
65162-511-6065162051160100 TABLET in 1 BLISTER PACK (65162-511-60) 100 tablet2010-08-020000-00-00NoNoCurrent