FDA.reportPublic FDA data

Spironolactone

Product NDC
68788-8381
11-digit product format
687888381
Labeler code
68788
Product ID
68788-8381_fa4ec5d1-d864-40f3-bdd0-47ff9d87586d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Spironolactone
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc
Application
ANDA040750
Marketing category
ANDA
Marketing start
2023-02-28
Substance
SPIRONOLACTONE
Active strength
100 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
SPIRONOLACTONE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii27O7W4T232
Rxcui198222

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
68788-8381-3Spironolactone30 in 1 BOTTLETABLET, COATED303
68788-8381-6Spironolactone60 in 1 BOTTLETABLET, COATED603
68788-8381-9Spironolactone90 in 1 BOTTLETABLET, COATED903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8381-3EA - Each68788-838149a66d25-cc2b-4d9d-b408-bd4bc381194512023-06-06
68788-8381-6EA - Each68788-838106b14247-f2d2-47e6-b5ac-0a20786ee6b712023-06-06
68788-8381-9EA - Each68788-8381c44bed56-a52b-4366-a73a-c22efabd94fa12023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8381SPIRONOLACTONE TABLET, COATED [PREFERRED PHARMACEUTICALS, INC]2Current NDC, 3 package rows20240814_b68235bb-0940-4810-bbf4-2a7a0881de68.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198222spironolactone 100 MG Oral TabletPSNb68235bb-0940-4810-bbf4-2a7a0881de683
198222spironolactone 100 MG Oral TabletSCDb68235bb-0940-4810-bbf4-2a7a0881de683

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68788-8381-36878883810330 TABLET, COATED in 1 BOTTLE (68788-8381-3) 2023-02-28NoNoHistorical
68788-8381-66878883810660 TABLET, COATED in 1 BOTTLE (68788-8381-6) 2023-02-28NoNoHistorical
68788-8381-96878883810990 TABLET, COATED in 1 BOTTLE (68788-8381-9) 2023-02-28NoNoHistorical