FDA.reportPublic FDA data

SPIRONOLACTONE

Product NDC
50090-6408
11-digit product format
500906408
Labeler code
50090
Product ID
50090-6408_02a97c35-9b10-4959-939d-2082af155165
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
50 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
SPIRONOLACTONE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii27O7W4T232
Rxcui198223

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
50090-6408-0SPIRONOLACTONE100 in 1 BOTTLETABLET, FILM COATED1003
50090-6408-1SPIRONOLACTONE90 in 1 BOTTLETABLET, FILM COATED903
50090-6408-2SPIRONOLACTONE30 in 1 BOTTLETABLET, FILM COATED303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6408-0EA - Each50090-6408533415d9-d6e4-49d8-b275-c20c604a626c12023-05-05
50090-6408-1EA - Each50090-640815f26a2a-f400-4f82-a83c-217ba29ffd6812023-05-05
50090-6408-2EA - Each50090-6408f731b068-2458-4ab7-84e1-68965f19615412023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6408SPIRONOLACTONE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]3Current NDC, 3 package rows20230603_be568fbd-3c3d-417c-ae96-75a78ca4b7cd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198223spironolactone 50 MG Oral TabletPSNbe568fbd-3c3d-417c-ae96-75a78ca4b7cd3
198223spironolactone 50 MG Oral TabletSCDbe568fbd-3c3d-417c-ae96-75a78ca4b7cd3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-6408-050090640800100 TABLET, FILM COATED in 1 BOTTLE (50090-6408-0) 2023-03-23NoNoCurrent
50090-6408-15009064080190 TABLET, FILM COATED in 1 BOTTLE (50090-6408-1) 2023-03-23NoNoCurrent
50090-6408-25009064080230 TABLET, FILM COATED in 1 BOTTLE (50090-6408-2) 2023-03-23NoNoCurrent