FDA.reportPublic FDA data

spironolactone

Product NDC
51655-153
11-digit product format
516550153
Labeler code
51655
Product ID
51655-153_49887127-b961-993f-e063-6294a90acaba
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
spironolactone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA205936
Marketing category
ANDA
Marketing start
2023-04-17
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
51655-153-262026-01-29C16284748780-149896155-a446-586f-e063-e6dba90add90These 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
51655-153-522026-01-29C16284748780-149896155-a446-586f-e063-e6dba90add90These 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
51655-153-26spironolactone90 in 1 BOTTLE, PLASTICTABLET, FILM COATED903
51655-153-52spironolactone30 in 1 BOTTLE, PLASTICTABLET, FILM COATED303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-153SPIRONOLACTONE TABLET [NORTHWIND PHARMACEUTICALS, LLC]2Current NDC, 2 package rows20230706_f988aa11-60ed-411e-e053-6294a90a522a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198222spironolactone 100 MG Oral TabletPSNf988aa11-60ed-411e-e053-6294a90a522a3
198222spironolactone 100 MG Oral TabletSCDf988aa11-60ed-411e-e053-6294a90a522a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
51655-153-265165501532690 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-153-26) 2023-04-17NoNoCurrent
51655-153-525165501535230 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-153-52) 2023-06-08NoNoCurrent