FDA.reportPublic FDA data

Spironolactone

Product NDC
50090-6369
11-digit product format
500906369
Labeler code
50090
Product ID
50090-6369_5cfdfcdf-5472-4384-a651-b8d4f65a19f7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Spironolactone
Dosage form
TABLET, COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA040750
Marketing category
ANDA
Marketing start
2021-01-04
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-6369-0Spironolactone100 in 1 BOTTLETABLET, COATED1004
50090-6369-1Spironolactone30 in 1 BOTTLETABLET, COATED304
50090-6369-6Spironolactone90 in 1 BOTTLETABLET, COATED904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6369-0EA - Each50090-63690dcdb71f-c4c7-4168-9f73-72620f0ef95912023-03-13
50090-6369-1EA - Each50090-63692385eaa4-0845-4397-b81a-d3bbccd1606212023-03-13
50090-6369-6EA - Each50090-6369eddda709-431a-402a-ace0-28d9de02dbc912023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6369SPIRONOLACTONE TABLET, COATED [A-S MEDICATION SOLUTIONS]2Current NDC, 3 package rows20230217_bb29ea6f-c294-4895-9e9b-544d69651a35.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313096spironolactone 25 MG Oral TabletPSNbb29ea6f-c294-4895-9e9b-544d69651a354
313096spironolactone 25 MG Oral TabletSCDbb29ea6f-c294-4895-9e9b-544d69651a354

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-6369-050090636900100 TABLET, COATED in 1 BOTTLE (50090-6369-0) 2023-02-10NoNoCurrent
50090-6369-15009063690130 TABLET, COATED in 1 BOTTLE (50090-6369-1) 2023-02-16NoNoCurrent
50090-6369-65009063690690 TABLET, COATED in 1 BOTTLE (50090-6369-6) 2023-02-16NoNoCurrent