FDA.reportPublic FDA data

Spironolactone

Product NDC
50090-6458
11-digit product format
500906458
Labeler code
50090
Product ID
50090-6458_17f7df99-eeea-4589-9c3e-5901a411447f
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
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
50090-6458-0Spironolactone100 in 1 BOTTLETABLET, COATED1005
50090-6458-1Spironolactone90 in 1 BOTTLETABLET, COATED905
50090-6458-2Spironolactone30 in 1 BOTTLETABLET, COATED305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6458-0EA - Each50090-645813b2a6b8-ad82-4f5f-b4f6-9e6e5874731f12023-06-06
50090-6458-1EA - Each50090-6458ac15c0aa-9a7a-4297-9274-b1f9a5dd7aab12023-06-06
50090-6458-2EA - Each50090-645817d40499-14c9-4ad2-a21a-a6167b4a801d12023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6458SPIRONOLACTONE TABLET, COATED [A-S MEDICATION SOLUTIONS]3Current NDC, 3 package rows20230504_c328f555-2da8-43ac-bc04-0e89d4d2aa53.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198223spironolactone 50 MG Oral TabletPSNc328f555-2da8-43ac-bc04-0e89d4d2aa535
198223spironolactone 50 MG Oral TabletSCDc328f555-2da8-43ac-bc04-0e89d4d2aa535

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-6458-050090645800100 TABLET, COATED in 1 BOTTLE (50090-6458-0) 2023-05-01NoNoCurrent
50090-6458-15009064580190 TABLET, COATED in 1 BOTTLE (50090-6458-1) 2023-05-01NoNoCurrent
50090-6458-25009064580230 TABLET, COATED in 1 BOTTLE (50090-6458-2) 2023-05-01NoNoCurrent