FDA.reportPublic FDA data

Spironolactone

Product NDC
63187-841
11-digit product format
631870841
Labeler code
63187
Product ID
63187-841_2ddce055-13bf-4f0b-9435-635d6118e631
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
spironolactone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA203253
Marketing category
ANDA
Marketing start
2013-02-01
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
Rxcui313096

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
63187-841-03Spironolactone03 in 1 BOTTLETABLET, FILM COATED034
63187-841-30Spironolactone30 in 1 BOTTLETABLET, FILM COATED304
63187-841-60Spironolactone60 in 1 BOTTLETABLET, FILM COATED604
63187-841-90Spironolactone90 in 1 BOTTLETABLET, FILM COATED904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-841-03EA - Each63187-841db839501-3e51-465e-8692-73ceaaa0df9512017-06-15
63187-841-60EA - Each63187-8410816e200-032e-4d20-8e97-6cda89d17b5812017-10-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-841SPIRONOLACTONE TABLET, FILM COATED [PROFICIENT RX LP]4Current NDC, Legacy NDC, 4 package rows20221102_5c2ae130-8e84-4c3f-b190-82691312fcbd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313096spironolactone 25 MG Oral TabletPSN5c2ae130-8e84-4c3f-b190-82691312fcbd4
313096spironolactone 25 MG Oral TabletSCD5c2ae130-8e84-4c3f-b190-82691312fcbd4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-841-03631870841033 TABLET, FILM COATED in 1 BOTTLE (63187-841-03) 2017-05-010000-00-00NoNoCurrent
63187-841-306318708413030 TABLET, FILM COATED in 1 BOTTLE (63187-841-30) 2017-05-010000-00-00NoNoCurrent
63187-841-606318708416060 TABLET, FILM COATED in 1 BOTTLE (63187-841-60) 2017-05-010000-00-00NoNoCurrent
63187-841-906318708419090 TABLET, FILM COATED in 1 BOTTLE (63187-841-90) 2017-05-010000-00-00NoNoCurrent