Spironolactone

Product NDC
53217-240
11-digit product format
532170240
Labeler code
53217
Product ID
53217-240_a6fe390d-8058-4a31-b19f-a8c04af26f73
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
spironolactone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA203253
Marketing category
ANDA
Marketing start
2013-02-01
Marketing end
0000-00-00
Substance
SPIRONOLACTONE
Active strength
25 mg/1
Pharmacologic classes
Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

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
53217-240-302020-01-31C16284748780-19d75b9d0-09d3-f424-e053-dadaa90a57ceSpironolactone Tablets, USP
53217-240-602020-01-31C16284748780-19d75b9d0-09d3-f424-e053-dadaa90a57ceSpironolactone Tablets, USP
53217-240-902020-01-31C16284748780-19d75b9d0-09d3-f424-e053-dadaa90a57ceSpironolactone Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53217-240-30Spironolactone30 in 1 BOTTLETABLET, FILM COATED301
53217-240-60Spironolactone60 in 1 BOTTLETABLET, FILM COATED601
53217-240-90Spironolactone90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53217-240SPIRONOLACTONE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 3 package rows20161130_41731c79-a024-4098-9b60-0fa271a7b787.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313096spironolactone 25 MG Oral TabletPSN41731c79-a024-4098-9b60-0fa271a7b7871
313096spironolactone 25 MG Oral TabletSCD41731c79-a024-4098-9b60-0fa271a7b7871

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53217-240-305321702403030 in 1 BOTTLEHistorical
53217-240-605321702406060 in 1 BOTTLEHistorical
53217-240-905321702409090 in 1 BOTTLEHistorical