Spironolactone

Product NDC
61919-772
11-digit product format
619190772
Labeler code
61919
Product ID
61919-772_eac58823-b7ff-51cc-e053-2995a90a69cd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Spironolactone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Direct_Rx
Application
ANDA203512
Marketing category
ANDA
Marketing start
2019-01-14
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
61919-772-302025-01-30C16284748780-12cef2736-98b2-d83d-e063-dadaa90ab31fSpironolactone
61919-772-902025-01-30C16284748780-12cef2736-98b2-d83d-e063-dadaa90ab31fSpironolactone

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-772-30Spironolactone30 in 1 BOTTLETABLET, FILM COATED303
61919-772-90Spironolactone90 in 1 BOTTLETABLET, FILM COATED903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-772-30EA - Each61919-772c937754f-e8d4-4b0b-a17e-bf6a173e61c412019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-772SPIRONOLACTONE TABLET, FILM COATED [DIRECT_RX]3Legacy NDC, 2 package rows20221012_7f6eb496-5b4b-9798-e053-2991aa0adfc6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313096spironolactone 25 MG Oral TabletPSN7f6eb496-5b4b-9798-e053-2991aa0adfc63
313096spironolactone 25 MG Oral TabletSCD7f6eb496-5b4b-9798-e053-2991aa0adfc63

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-772-306191907723030 TABLET, FILM COATED in 1 BOTTLE (61919-772-30) 2019-01-140000-00-00NoNoCurrent
61919-772-906191907729090 TABLET, FILM COATED in 1 BOTTLE (61919-772-90) 2019-01-140000-00-00NoNoCurrent