Spironolactone

Product NDC
21695-960
11-digit product format
216950960
Labeler code
21695
Product ID
21695-960_e5bf608e-c6dd-44e8-96aa-ba4660f64de0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
spironolactone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA040750
Marketing category
ANDA
Marketing start
2006-08-29
Marketing end
0000-00-00
Substance
SPIRONOLACTONE
Active strength
50 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
21695-960-602019-09-24C16284748780-1934fe258-4aee-48b1-e053-8cdaa90a720aSPIRONOLACTONE TABLETS, USP 25 mg, 50 mg, 100 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-960-60Spironolactone60 in 1 BOTTLE, PLASTICTABLET, FILM COATED601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-960SPIRONOLACTONE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20110914_e5bf608e-c6dd-44e8-96aa-ba4660f64de0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198223spironolactone 50 MG Oral TabletPSNe5bf608e-c6dd-44e8-96aa-ba4660f64de01
198223spironolactone 50 MG Oral TabletSCDe5bf608e-c6dd-44e8-96aa-ba4660f64de01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-960-602169509606060 in 1 BOTTLE, PLASTICHistorical