Spironolactone

Product NDC
67296-1403
11-digit product format
672961403
Labeler code
67296
Product ID
67296-1403_d61b8590-e67d-5657-e053-2a95a90abdd0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Spironolactone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
RedPharm Drug, Inc.
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
2023-12-31
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
67296-1403-32024-01-30C16284748780-11030e365-679e-111a-e063-dadaa90a10e250d3dfb4-c679-1a3f-e054-00144ff88e88

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1403-3Spironolactone30 in 1 BOTTLETABLET, FILM COATED304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1403SPIRONOLACTONE TABLET, FILM COATED [REDPHARM DRUG, INC.]4Legacy NDC, 1 package rows20220122_50d3dfb4-c679-1a3f-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313096spironolactone 25 MG Oral TabletPSN50d3dfb4-c679-1a3f-e054-00144ff88e884
313096spironolactone 25 MG Oral TabletSCD50d3dfb4-c679-1a3f-e054-00144ff88e884

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67296-1403-36729614030330 TABLET, FILM COATED in 1 BOTTLE (67296-1403-3) 2013-02-010000-00-00NoNoCurrent