FDA.reportPublic FDA data

Spironolactone

Product NDC
68788-8452
11-digit product format
687888452
Labeler code
68788
Product ID
68788-8452_54a64ac4-2d50-427f-a306-a2e705015502
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Spironolactone
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA040750
Marketing category
ANDA
Marketing start
2023-05-30
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
68788-8452-3Spironolactone30 in 1 BOTTLETABLET, COATED303
68788-8452-6Spironolactone60 in 1 BOTTLETABLET, COATED603
68788-8452-9Spironolactone90 in 1 BOTTLETABLET, COATED903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8452-3EA - Each68788-84524fac94e3-6049-4af1-bc27-9422b285255912023-07-06
68788-8452-6EA - Each68788-8452cf3b98e8-de96-4ead-bf7a-04eebfabc54712023-07-06
68788-8452-9EA - Each68788-84524f13ba25-3eda-4944-bd53-8b3339d86a4c12023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8452SPIRONOLACTONE TABLET, COATED [PREFERRED PHARMACEUTICALS INC.]2Current NDC, 3 package rows20240814_5e456f3c-f93e-41c6-80c5-a737ed70feda.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198223spironolactone 50 MG Oral TabletPSN5e456f3c-f93e-41c6-80c5-a737ed70feda3
198223spironolactone 50 MG Oral TabletSCD5e456f3c-f93e-41c6-80c5-a737ed70feda3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68788-8452-36878884520330 TABLET, COATED in 1 BOTTLE (68788-8452-3) 2023-05-30NoNoCurrent
68788-8452-66878884520660 TABLET, COATED in 1 BOTTLE (68788-8452-6) 2023-05-30NoNoCurrent
68788-8452-96878884520990 TABLET, COATED in 1 BOTTLE (68788-8452-9) 2023-05-30NoNoCurrent