FDA.reportPublic FDA data

SPIRONOLACTONE

Product NDC
50090-7082
11-digit product format
500907082
Labeler code
50090
Product ID
50090-7082_fa66aeea-0c90-466a-8da2-8f8940ed236f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SPIRONOLACTONE
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA202187
Marketing category
ANDA
Marketing start
2019-12-13
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
50090-7082-0SPIRONOLACTONE100 in 1 BOTTLETABLET1005
50090-7082-1SPIRONOLACTONE90 in 1 BOTTLETABLET905
50090-7082-2SPIRONOLACTONE30 in 1 BOTTLETABLET305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7082-0EA - Each50090-7082fc915270-5eec-4977-8551-dc73df0bf7b812024-03-12
50090-7082-1EA - Each50090-7082f7721639-3b75-4af1-b52f-a2993d1ddf9612024-03-12
50090-7082-2EA - Each50090-7082a0f79cd3-a02f-4695-a03e-4ef07e7f460b12024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7082SPIRONOLACTONE TABLET [A-S MEDICATION SOLUTIONS]5Current NDC, 3 package rows20240830_a73e3dd9-4958-4a2c-853f-45b2810b1639.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198223spironolactone 50 MG Oral TabletPSNa73e3dd9-4958-4a2c-853f-45b2810b16395
198223spironolactone 50 MG Oral TabletSCDa73e3dd9-4958-4a2c-853f-45b2810b16395

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-7082-050090708200100 TABLET in 1 BOTTLE (50090-7082-0) 100 tablet2024-02-05NoNoHistorical
50090-7082-15009070820190 TABLET in 1 BOTTLE (50090-7082-1) 90 tablet2024-02-05NoNoHistorical
50090-7082-25009070820230 TABLET in 1 BOTTLE (50090-7082-2) 30 tablet2024-02-05NoNoHistorical