FDA.reportPublic FDA data

Spironolactone

Product NDC
42708-101
11-digit product format
427080101
Labeler code
42708
Product ID
42708-101_458698e8-b92c-e278-e063-6394a90a1a05
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
spironolactone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
QPharma, Inc.
Application
ANDA203253
Marketing category
ANDA
Marketing start
2013-02-01
Substance
SPIRONOLACTONE
Active strength
25 mg/1
Pharmacologic classes
Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Spironolactone
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SPIRONOLACTONE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii27O7W4T232
Rxcui313096

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
42708-101-302021-03-15C16284748780-1ba0f9c33-3e07-a910-e053-dadaa90a0b85These 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
42708-101-302021-01-29C16284748780-1ba0f9c33-3e07-a910-e053-dadaa90a0b85These 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
42708-101-30Spironolactone30 in 1 BOTTLETABLET, FILM COATED306

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42708-101SPIRONOLACTONE TABLET, FILM COATED [QPHARMA, INC.]5Current NDC, Legacy NDC, 1 package rows20250521_37066684-5b63-4d3e-ae6a-08c4b3edd7aa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313096spironolactone 25 MG Oral TabletPSN37066684-5b63-4d3e-ae6a-08c4b3edd7aa6
313096spironolactone 25 MG Oral TabletSCD37066684-5b63-4d3e-ae6a-08c4b3edd7aa6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42708-101-304270801013030 TABLET, FILM COATED in 1 BOTTLE (42708-101-30) 2019-10-180000-00-00YesNoCurrent