FDA.reportPublic FDA data

Spironolactone

Product NDC
59746-217
11-digit product format
597460217
Labeler code
59746
Product ID
59746-217_7839b797-5078-4aab-93a5-6056e4b9cdd5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
spironolactone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Jubilant Cadista Pharmacuticals Inc.
Application
ANDA203253
Marketing category
ANDA
Marketing start
2013-02-01
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
2026-12-31

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59746-217-012023-05-08C16284748780-1f386c649-af6a-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use SPIRONOLACTONE TABLETS safely and effectively. See full prescribing information for SPIRONOLACTONE TABLETS. SPIRONOLACTONE tablets, for oral use Initial U.S. Approval: 1960
59746-217-052023-05-08C16284748780-1f386c649-af6a-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use SPIRONOLACTONE TABLETS safely and effectively. See full prescribing information for SPIRONOLACTONE TABLETS. SPIRONOLACTONE tablets, for oral use Initial U.S. Approval: 1960
59746-217-012023-01-30C16284748780-1f386c649-af6a-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use SPIRONOLACTONE TABLETS safely and effectively. See full prescribing information for SPIRONOLACTONE TABLETS. SPIRONOLACTONE tablets, for oral use Initial U.S. Approval: 1960
59746-217-052023-01-30C16284748780-1f386c649-af6a-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use SPIRONOLACTONE TABLETS safely and effectively. See full prescribing information for SPIRONOLACTONE TABLETS. SPIRONOLACTONE tablets, for oral use Initial U.S. Approval: 1960

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59746-217-01Spironolactone100 in 1 BOTTLETABLET, FILM COATED1008
59746-217-05Spironolactone500 in 1 BOTTLETABLET, FILM COATED5008
59746-217-06Spironolactone100 in 1 BOTTLETABLET, FILM COATED1001
59746-217-09Spironolactone500 in 1 BOTTLETABLET, FILM COATED5001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59746-217-01EA - Each59746-217ee003931-0261-4ec3-bfbc-2389a518d3e612015-01-05
59746-217-06EA - Each59746-217e48f6616-3861-4e11-9382-72bf188dc62912025-05-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
spironolactoneACTIVE INGREDIENT27O7W4T232SPIRONOLACTONE (SPIRONOLACTONE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.]4
spironolactoneACTIVE MOIETY27O7W4T232SPIRONOLACTONE (SPIRONOLACTONE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.]4
calcium sulfateINACTIVE INGREDIENTWAT0DDB505SPIRONOLACTONE (SPIRONOLACTONE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.]4
Calcium Sulfate DihydrateINACTIVE INGREDIENT4846Q921YMSPIRONOLACTONE (SPIRONOLACTONE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.]4
Ferric Oxide RedINACTIVE INGREDIENT1K09F3G675SPIRONOLACTONE (SPIRONOLACTONE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.]4
Ferric Oxide YellowINACTIVE INGREDIENTEX438O2MRTSPIRONOLACTONE (SPIRONOLACTONE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.]4
Ferrosoferric OxideINACTIVE INGREDIENTXM0M87F357SPIRONOLACTONE (SPIRONOLACTONE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.]4
HypromellosesINACTIVE INGREDIENT3NXW29V3WOSPIRONOLACTONE (SPIRONOLACTONE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.]4
magnesium stearateINACTIVE INGREDIENT70097M6I30SPIRONOLACTONE (SPIRONOLACTONE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.]4
PeppermintINACTIVE INGREDIENTV95R5KMY2BSPIRONOLACTONE (SPIRONOLACTONE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.]4
Polyethylene GlycolsINACTIVE INGREDIENT3WJQ0SDW1ASPIRONOLACTONE (SPIRONOLACTONE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.]4
povidoneINACTIVE INGREDIENTFZ989GH94ESPIRONOLACTONE (SPIRONOLACTONE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.]4
starch, cornINACTIVE INGREDIENTO8232NY3SJSPIRONOLACTONE (SPIRONOLACTONE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.]4
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPSPIRONOLACTONE (SPIRONOLACTONE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59746-217SPIRONOLACTONE (SPIRONOLACTONE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACUTICALS INC.]8Current NDC, Legacy NDC, 2 package rows20240728_a7510768-8a52-4230-6aa0-b0d92d82588f.zip
59746-217SPIRONOLACTONE TABLET, FILM COATED SPIRONOLACTONE TABLET, FILM COATED [JUBILANT CADISTA PHARMACUTICALS INC.]1Current NDC, Legacy NDC, 2 package rows20240810_c1c5fdab-3ff7-414b-8e25-beed8311b8ad.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198223spironolactone 50 MG Oral TabletPSN9d747bf5-31aa-48a5-9c6d-3cf8ce99a8f1103
198223spironolactone 50 MG Oral TabletSCD9d747bf5-31aa-48a5-9c6d-3cf8ce99a8f1103
198223spironolactone 50 MG Oral TabletPSNb5b129b8-aed9-4d94-a35e-e92647effbdb101
198223spironolactone 50 MG Oral TabletSCDb5b129b8-aed9-4d94-a35e-e92647effbdb101
198222spironolactone 100 MG Oral TabletPSNa7510768-8a52-4230-6aa0-b0d92d82588f8
313096spironolactone 25 MG Oral TabletPSNa7510768-8a52-4230-6aa0-b0d92d82588f8
198223spironolactone 50 MG Oral TabletPSNa7510768-8a52-4230-6aa0-b0d92d82588f8
198222spironolactone 100 MG Oral TabletSCDa7510768-8a52-4230-6aa0-b0d92d82588f8
313096spironolactone 25 MG Oral TabletSCDa7510768-8a52-4230-6aa0-b0d92d82588f8
198223spironolactone 50 MG Oral TabletSCDa7510768-8a52-4230-6aa0-b0d92d82588f8
198223spironolactone 50 MG Oral TabletPSNcaf9c845-63eb-40bd-8261-0582abdf705a3
198223spironolactone 50 MG Oral TabletSCDcaf9c845-63eb-40bd-8261-0582abdf705a3
198222spironolactone 100 MG Oral TabletPSNc1c5fdab-3ff7-414b-8e25-beed8311b8ad1
313096spironolactone 25 MG Oral TabletPSNc1c5fdab-3ff7-414b-8e25-beed8311b8ad1
198223spironolactone 50 MG Oral TabletPSNc1c5fdab-3ff7-414b-8e25-beed8311b8ad1
198222spironolactone 100 MG Oral TabletSCDc1c5fdab-3ff7-414b-8e25-beed8311b8ad1
313096spironolactone 25 MG Oral TabletSCDc1c5fdab-3ff7-414b-8e25-beed8311b8ad1
198223spironolactone 50 MG Oral TabletSCDc1c5fdab-3ff7-414b-8e25-beed8311b8ad1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59746-217-0159746021701100 TABLET, FILM COATED in 1 BOTTLE (59746-217-01) 2017-04-040000-00-00NoNoCurrent
59746-217-0559746021705500 TABLET, FILM COATED in 1 BOTTLE (59746-217-05) 2017-04-040000-00-00NoNoCurrent
59746-217-0659746021706100 TABLET, FILM COATED in 1 BOTTLE (59746-217-06) 2017-04-04NoNoHistorical
59746-217-0959746021709500 TABLET, FILM COATED in 1 BOTTLE (59746-217-09) 2017-04-04NoNoHistorical