FDA.reportPublic FDA data

SPIRONOLACTONE

Product NDC
59651-428
11-digit product format
596510428
Labeler code
59651
Product ID
59651-428_9b6802a0-5117-4be3-a113-9098e8dcedaa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SPIRONOLACTONE
Dosage form
TABLET
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA202187
Marketing category
ANDA
Marketing start
2019-12-13
Substance
SPIRONOLACTONE
Active strength
100 mg/1
Pharmacologic classes
Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
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
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
59651-428-01SPIRONOLACTONE100 in 1 BOTTLETABLET1008
59651-428-05SPIRONOLACTONE500 in 1 BOTTLETABLET5008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-428-01EA - Each59651-4282ed65603-017b-4d7e-bb61-be491339a95912023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-428SPIRONOLACTONE TABLET [AUROBINDO PHARMA LIMITED]7Current NDC, Legacy NDC, 2 package rows20230829_768563dc-a619-44dc-b97f-1a7e71fd56a0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198222spironolactone 100 MG Oral TabletPSN768563dc-a619-44dc-b97f-1a7e71fd56a08
313096spironolactone 25 MG Oral TabletPSN768563dc-a619-44dc-b97f-1a7e71fd56a08
198223spironolactone 50 MG Oral TabletPSN768563dc-a619-44dc-b97f-1a7e71fd56a08
198222spironolactone 100 MG Oral TabletSCD768563dc-a619-44dc-b97f-1a7e71fd56a08
313096spironolactone 25 MG Oral TabletSCD768563dc-a619-44dc-b97f-1a7e71fd56a08
198223spironolactone 50 MG Oral TabletSCD768563dc-a619-44dc-b97f-1a7e71fd56a08
198222spironolactone 100 MG Oral TabletPSNf98cc3be-cf59-e3d2-e053-6294a90a2ae03
198222spironolactone 100 MG Oral TabletSCDf98cc3be-cf59-e3d2-e053-6294a90a2ae03
198222spironolactone 100 MG Oral TabletPSN860b08bf-c6c1-4310-8510-10b6779f3d592
198222spironolactone 100 MG Oral TabletSCD860b08bf-c6c1-4310-8510-10b6779f3d592

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59651-428-0159651042801100 TABLET in 1 BOTTLE (59651-428-01) 100 tablet2019-12-130000-00-00NoNoCurrent
59651-428-0559651042805500 TABLET in 1 BOTTLE (59651-428-05) 500 tablet2023-08-24NoNoCurrent