FDA.reportPublic FDA data

SPIRONOLACTONE

Product NDC
59651-426
11-digit product format
596510426
Labeler code
59651
Product ID
59651-426_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
25 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
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
59651-426-01SPIRONOLACTONE100 in 1 BOTTLETABLET1008
59651-426-05SPIRONOLACTONE500 in 1 BOTTLETABLET5008
59651-426-99SPIRONOLACTONE1000 in 1 BOTTLETABLET10008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-426-01EA - Each59651-4267f61e096-e79f-4cdb-87fd-18d53c02d2c412023-01-09
59651-426-05EA - Each59651-426b7445534-0fb5-45ee-8579-bdc3ba2b202512023-01-09
59651-426-99EA - Each59651-426736431d8-3c1a-460f-90e6-6647a7c8a45112023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-426SPIRONOLACTONE TABLET [AUROBINDO PHARMA LIMITED]7Current NDC, Legacy NDC, 3 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
313096spironolactone 25 MG Oral TabletPSNe34fc3ca-1272-446b-8dc2-25b62add01c38
198223spironolactone 50 MG Oral TabletPSN768563dc-a619-44dc-b97f-1a7e71fd56a08
198223spironolactone 50 MG Oral TabletPSNe34fc3ca-1272-446b-8dc2-25b62add01c38
198222spironolactone 100 MG Oral TabletSCD768563dc-a619-44dc-b97f-1a7e71fd56a08
313096spironolactone 25 MG Oral TabletSCD768563dc-a619-44dc-b97f-1a7e71fd56a08
313096spironolactone 25 MG Oral TabletSCDe34fc3ca-1272-446b-8dc2-25b62add01c38
198223spironolactone 50 MG Oral TabletSCD768563dc-a619-44dc-b97f-1a7e71fd56a08
198223spironolactone 50 MG Oral TabletSCDe34fc3ca-1272-446b-8dc2-25b62add01c38
313096spironolactone 25 MG Oral TabletPSNf9b79b4a-1a48-6247-e053-6394a90a2ae13
313096spironolactone 25 MG Oral TabletSCDf9b79b4a-1a48-6247-e053-6394a90a2ae13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59651-426-0159651042601100 TABLET in 1 BOTTLE (59651-426-01) 100 tablet2019-12-130000-00-00NoNoCurrent
59651-426-0559651042605500 TABLET in 1 BOTTLE (59651-426-05) 500 tablet2019-12-130000-00-00NoNoCurrent
59651-426-99596510426991000 TABLET in 1 BOTTLE (59651-426-99) 1000 tablet2019-12-130000-00-00NoNoCurrent