FDA.reportPublic FDA data

Spironolactone

Product NDC
51655-344
11-digit product format
516550344
Labeler code
51655
Product ID
51655-344_48eb2ef1-10f5-aa75-e063-6294a90a901f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
spironolactone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA203512
Marketing category
ANDA
Marketing start
2020-05-27
Substance
SPIRONOLACTONE
Active strength
100 mg/1
Pharmacologic classes
Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Spironolactone
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SPIRONOLACTONE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii27O7W4T232
Rxcui198222

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
51655-344-262023-03-27C16284748780-1f386c649-d8ae-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use SPIRONOLACTONE TABLETS safely and effectively. See full prescribing information for SPIRONOLACTONE TABLETS. SPIRONOLACTONE tablets for oral use Initial U.S. Approval: 1960
51655-344-262023-01-30C16284748780-1f386c649-d8ae-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use SPIRONOLACTONE TABLETS safely and effectively. See full prescribing information for SPIRONOLACTONE TABLETS. SPIRONOLACTONE tablets for oral use Initial U.S. Approval: 1960

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51655-344-26Spironolactone90 in 1 BOTTLETABLET, FILM COATED905
51655-344-52Spironolactone30 in 1 BOTTLE, PLASTICTABLET, FILM COATED305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-344SPIRONOLACTONE TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC]4Current NDC, Legacy NDC, 2 package rows20241219_ab3090fc-458c-17c1-e053-2995a90a6ffa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198222spironolactone 100 MG Oral TabletPSNab3090fc-458c-17c1-e053-2995a90a6ffa5
198222spironolactone 100 MG Oral TabletSCDab3090fc-458c-17c1-e053-2995a90a6ffa5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51655-344-265165503442690 TABLET, FILM COATED in 1 BOTTLE (51655-344-26) 2020-05-270000-00-00NoNoCurrent
51655-344-525165503445230 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-344-52) 2020-08-24NoNoCurrent