FDA.reportPublic FDA data

SPIRONOLACTONE

Product NDC
50090-6432
11-digit product format
500906432
Labeler code
50090
Product ID
50090-6432_aba7ca7e-edbd-4b42-8491-4b0f6361bab8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SPIRONOLACTONE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA089424
Marketing category
ANDA
Marketing start
1986-07-23
Substance
SPIRONOLACTONE
Active strength
100 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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-6432-0SPIRONOLACTONE90 in 1 BOTTLETABLET, FILM COATED9012
50090-6432-1SPIRONOLACTONE30 in 1 BOTTLETABLET, FILM COATED3012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6432-0EA - Each50090-6432db4c09e7-3ed6-4b18-9adf-62d6eeccdaa112023-05-05
50090-6432-1EA - Each50090-64323836780e-b613-45da-9aa8-c649abfd635312023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6432SPIRONOLACTONE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]12Current NDC, 2 package rows20230418_4514fa40-613e-46f5-bee4-3edc7cc9863f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198222spironolactone 100 MG Oral TabletPSN4514fa40-613e-46f5-bee4-3edc7cc9863f12
198222spironolactone 100 MG Oral TabletSCD4514fa40-613e-46f5-bee4-3edc7cc9863f12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-6432-05009064320090 TABLET, FILM COATED in 1 BOTTLE (50090-6432-0) 2023-04-11NoNoCurrent
50090-6432-15009064320130 TABLET, FILM COATED in 1 BOTTLE (50090-6432-1) 2023-04-11NoNoCurrent