FDA.reportPublic FDA data

SPIRONOLACTONE

Product NDC
50090-6908
11-digit product format
500906908
Labeler code
50090
Product ID
50090-6908_b8981ce7-0475-490c-9035-71717a62124c
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
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
50090-6908-0SPIRONOLACTONE100 in 1 BOTTLETABLET1001
50090-6908-1SPIRONOLACTONE30 in 1 BOTTLETABLET301
50090-6908-6SPIRONOLACTONE90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6908-0EA - Each50090-6908855341d4-6cc9-47a3-993e-cbf6f40e323512024-02-14
50090-6908-1EA - Each50090-6908d07aae99-b5a5-4c90-905b-814c0fa58a5012024-02-14
50090-6908-6EA - Each50090-6908f5353526-e6bb-44f3-a102-cf5bcc1a262512024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6908SPIRONOLACTONE TABLET [A-S MEDICATION SOLUTIONS]1Current NDC, 3 package rows20231218_7ef0c2bb-9657-419e-848c-858893be50bc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313096spironolactone 25 MG Oral TabletPSN7ef0c2bb-9657-419e-848c-858893be50bc1
313096spironolactone 25 MG Oral TabletSCD7ef0c2bb-9657-419e-848c-858893be50bc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-6908-050090690800100 TABLET in 1 BOTTLE (50090-6908-0) 100 tablet2023-12-12NoNoCurrent
50090-6908-15009069080130 TABLET in 1 BOTTLE (50090-6908-1) 30 tablet2023-12-12NoNoCurrent
50090-6908-65009069080690 TABLET in 1 BOTTLE (50090-6908-6) 90 tablet2023-12-12NoNoCurrent