FDA.reportPublic FDA data

Spironolactone

Product NDC
50090-3747
11-digit product format
500903747
Labeler code
50090
Product ID
50090-3747_81a3f77c-3d85-408a-a642-afc7cee5c1a8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
spironolactone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA203512
Marketing category
ANDA
Marketing start
2017-06-02
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
50090-3747-02023-02-07C16284748780-1f386c64a-3645-0266-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 (spironolactone) tablets for oral use Initial U.S. Approval: 1960
50090-3747-12023-02-07C16284748780-1f386c64a-3645-0266-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 (spironolactone) tablets for oral use Initial U.S. Approval: 1960
50090-3747-62023-02-07C16284748780-1f386c64a-3645-0266-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 (spironolactone) tablets for oral use Initial U.S. Approval: 1960
50090-3747-02023-01-30C16284748780-1f386c64a-3645-0266-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 (spironolactone) tablets for oral use Initial U.S. Approval: 1960
50090-3747-12023-01-30C16284748780-1f386c64a-3645-0266-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 (spironolactone) tablets for oral use Initial U.S. Approval: 1960
50090-3747-62023-01-30C16284748780-1f386c64a-3645-0266-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 (spironolactone) tablets for oral use Initial U.S. Approval: 1960

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3747-0Spironolactone100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1009
50090-3747-1Spironolactone30 in 1 BOTTLETABLET, FILM COATED309
50090-3747-6Spironolactone90 in 1 BOTTLE, PLASTICTABLET, FILM COATED909

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3747-0EA - Each50090-3747fa89206a-c6a5-4e93-83e3-a795638af3b312021-11-09
50090-3747-1EA - Each50090-3747cf899727-80d2-4572-bc9a-3c6bdfd8bfe312021-11-09
50090-3747-6EA - Each50090-3747c1982eae-9013-4583-8bc3-d13b95c0ab5612021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3747SPIRONOLACTONE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]9Current NDC, Legacy NDC, 3 package rows20230208_791251af-d276-40fc-8c35-9d179b20e219.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313096spironolactone 25 MG Oral TabletPSN791251af-d276-40fc-8c35-9d179b20e2199
313096spironolactone 25 MG Oral TabletSCD791251af-d276-40fc-8c35-9d179b20e2199

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-3747-050090374700100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-3747-0) 2017-06-020000-00-00NoNoCurrent
50090-3747-15009037470130 TABLET, FILM COATED in 1 BOTTLE (50090-3747-1) 2018-10-300000-00-00NoNoCurrent
50090-3747-65009037470690 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-3747-6) 2017-06-020000-00-00NoNoCurrent