Spironolactone

Product NDC
53808-0592
11-digit product format
538080592
Labeler code
53808
Product ID
53808-0592_563b3f57-28df-47cb-b929-86783f5414e1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
spironolactone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
State of Florida DOH Central Pharmacy
Application
ANDA040750
Marketing category
ANDA
Marketing start
2009-07-01
Marketing end
0000-00-00
Substance
SPIRONOLACTONE
Active strength
25 mg/1
Pharmacologic classes
Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
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
53808-0592-12019-10-21C16284748780-1956f9ecf-ddb2-621f-e053-dbdaa90a74adSPIRONOLACTONE TABLETS, USP 25 mg, 50 mg, 100 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-0592-1Spironolactone30 in 1 BLISTER PACKTABLET, FILM COATED301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-0592SPIRONOLACTONE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1Legacy NDC, 1 package rows20100611_7c850c17-9a7d-423a-86bd-ac108d1c7932.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198222spironolactone 100 MG Oral TabletPSN7c850c17-9a7d-423a-86bd-ac108d1c79321
313096spironolactone 25 MG Oral TabletPSN7c850c17-9a7d-423a-86bd-ac108d1c79321
198222spironolactone 100 MG Oral TabletSCD7c850c17-9a7d-423a-86bd-ac108d1c79321
313096spironolactone 25 MG Oral TabletSCD7c850c17-9a7d-423a-86bd-ac108d1c79321

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53808-0592-15380805920130 in 1 BLISTER PACKHistorical