FDA.reportPublic FDA data

SPIRONOLACTONE

Product NDC
68071-2989
11-digit product format
680712989
Labeler code
68071
Product ID
68071-2989_2d53de10-d7af-f4b7-e063-6294a90a92c6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SPIRONOLACTONE
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA202187
Marketing category
ANDA
Marketing start
2019-12-13
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
68071-2989-32025-02-04C16284748780-12cef2736-976c-d83d-e063-dadaa90ab31fThese 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
68071-2989-92025-02-04C16284748780-12cef2736-976c-d83d-e063-dadaa90ab31fThese 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
68071-2989-32025-01-30C16284748780-12cef2736-976c-d83d-e063-dadaa90ab31fThese 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
68071-2989-92025-01-30C16284748780-12cef2736-976c-d83d-e063-dadaa90ab31fThese 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
68071-2989-3SPIRONOLACTONE30 in 1 BOTTLETABLET303
68071-2989-9SPIRONOLACTONE90 in 1 BOTTLETABLET903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2989SPIRONOLACTONE TABLET [NUCARE PHARMACEUTICALS,INC.]3Current NDC, 2 package rows20250206_f9b79b4a-1a48-6247-e053-6394a90a2ae1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313096spironolactone 25 MG Oral TabletPSNf9b79b4a-1a48-6247-e053-6394a90a2ae13
313096spironolactone 25 MG Oral TabletSCDf9b79b4a-1a48-6247-e053-6394a90a2ae13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68071-2989-36807129890330 TABLET in 1 BOTTLE (68071-2989-3) 30 tablet2023-04-19NoNoCurrent
68071-2989-96807129890990 TABLET in 1 BOTTLE (68071-2989-9) 90 tablet2023-04-19NoNoCurrent