FDA.reportPublic FDA data

Spironolactone

Product NDC
68788-8545
11-digit product format
687888545
Labeler code
68788
Product ID
68788-8545_ef2d0478-7316-4884-9913-1bc39f5038e7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Spironolactone
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA040750
Marketing category
ANDA
Marketing start
2023-11-07
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
68788-8545-3Spironolactone30 in 1 BOTTLETABLET, COATED303
68788-8545-6Spironolactone60 in 1 BOTTLETABLET, COATED603
68788-8545-9Spironolactone90 in 1 BOTTLETABLET, COATED903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8545-3EA - Each68788-8545b5fc0adc-ff37-423e-8d22-889e30f8521612024-01-04
68788-8545-6EA - Each68788-8545960e9758-640a-4a07-be09-45a10fac9d2312024-01-04
68788-8545-9EA - Each68788-8545885ccfdd-3bf5-4d6c-a51e-f7879ff6ec3112024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8545SPIRONOLACTONE TABLET, COATED [PREFERRED PHARMACEUTICALS INC.]2Current NDC, 3 package rows20240814_4290b3ec-8993-47d4-bfe3-fcb81d7baed8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313096spironolactone 25 MG Oral TabletPSN4290b3ec-8993-47d4-bfe3-fcb81d7baed83
313096spironolactone 25 MG Oral TabletSCD4290b3ec-8993-47d4-bfe3-fcb81d7baed83

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68788-8545-36878885450330 TABLET, COATED in 1 BOTTLE (68788-8545-3) 2023-11-07NoNoHistorical
68788-8545-66878885450660 TABLET, COATED in 1 BOTTLE (68788-8545-6) 2023-11-07NoNoHistorical
68788-8545-96878885450990 TABLET, COATED in 1 BOTTLE (68788-8545-9) 2023-11-07NoNoHistorical