FDA.reportPublic FDA data

SPIRONOLACTONE

Product NDC
72162-1624
11-digit product format
721621624
Labeler code
72162
Product ID
72162-1624_a2903367-d7ba-42ba-b6c1-69c699e1016b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SPIRONOLACTONE
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA089424
Marketing category
ANDA
Marketing start
1986-07-23
Substance
SPIRONOLACTONE
Active strength
25 mg/1
Pharmacologic classes
Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
SPIRONOLACTONE
Listing expiration
2027-12-31

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
72162-1624-0SPIRONOLACTONE1000 in 1 BOTTLETABLET1000109
72162-1624-1SPIRONOLACTONE100 in 1 BOTTLETABLET100109
72162-1624-3SPIRONOLACTONE30 in 1 BOTTLETABLET30109
72162-1624-5SPIRONOLACTONE500 in 1 BOTTLETABLET500109
72162-1624-6SPIRONOLACTONE60 in 1 BOTTLETABLET60109
72162-1624-9SPIRONOLACTONE90 in 1 BOTTLETABLET90109

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1624-0EA - Each72162-162434b5f845-d3a5-4201-896c-c73588c47ac712025-05-14
72162-1624-1EA - Each72162-162478c7cae0-2b4e-460b-9ee2-b656d9ff70e612023-07-06
72162-1624-3EA - Each72162-16244b6fd20b-e72c-427e-a885-6f56a62abd0612024-01-04
72162-1624-5EA - Each72162-16247bcf5f56-f2e1-4fb5-b222-91784fd75fcf12024-10-04
72162-1624-6EA - Each72162-1624b437eb85-1aed-4bfd-a90f-51a1de6a35a812024-01-04
72162-1624-9EA - Each72162-1624e3032663-7f96-4db7-af35-45c81aa766ae12024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1624SPIRONOLACTONE TABLET [BRYANT RANCH PREPACK]108Current NDC, 6 package rows20250313_3791d79c-d960-4790-b689-ea32ddf7226a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313096spironolactone 25 MG Oral TabletPSN3791d79c-d960-4790-b689-ea32ddf7226a109
313096spironolactone 25 MG Oral TabletSCD3791d79c-d960-4790-b689-ea32ddf7226a109
313096spironolactone 25 MG Oral TabletPSN45232668-6952-80a0-e063-6294a90a6e4b2
313096spironolactone 25 MG Oral TabletSCD45232668-6952-80a0-e063-6294a90a6e4b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-1624-0721621624001000 TABLET in 1 BOTTLE (72162-1624-0) 1000 tablet2023-11-20NoNoHistorical
72162-1624-172162162401100 TABLET in 1 BOTTLE (72162-1624-1) 100 tablet2024-04-08NoNoHistorical
72162-1624-37216216240330 TABLET in 1 BOTTLE (72162-1624-3) 30 tablet2025-09-15NoNoHistorical
72162-1624-572162162405500 TABLET in 1 BOTTLE (72162-1624-5) 500 tablet2025-01-13NoNoHistorical
72162-1624-67216216240660 TABLET in 1 BOTTLE (72162-1624-6) 60 tablet2026-03-30NoNoHistorical
72162-1624-97216216240990 TABLET in 1 BOTTLE (72162-1624-9) 90 tablet2026-03-30NoNoHistorical