Spironolactone

Product NDC
67296-1100
11-digit product format
672961100
Labeler code
67296
Product ID
67296-1100_b8d07238-d549-1388-e053-2a95a90ac21c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Spironolactone
Dosage form
TABLET
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA091426
Marketing category
ANDA
Marketing start
2019-01-01
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
2022-12-31
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
67296-1100-32024-07-11C16284748780-1f386c64a-0ba8-0266-e053-dadaa90a7c1aSpironolactone 25mg
67296-1100-32023-01-30C16284748780-1f386c64a-0ba8-0266-e053-dadaa90a7c1aSpironolactone 25mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1100-3Spironolactone30 in 1 BOTTLETABLET307

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1100SPIRONOLACTONE TABLET [REDPHARM DRUG, INC.]7Legacy NDC, 1 package rows20240712_88615d0b-ab11-092b-e053-2a95a90ac418.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313096spironolactone 25 MG Oral TabletPSN88615d0b-ab11-092b-e053-2a95a90ac4187
313096spironolactone 25 MG Oral TabletSCD88615d0b-ab11-092b-e053-2a95a90ac4187

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67296-1100-36729611000330 TABLET in 1 BOTTLE (67296-1100-3) 30 tablet2019-01-010000-00-00NoNoCurrent