FDA.reportPublic FDA data

Spironolactone

Product NDC
72789-292
11-digit product format
727890292
Labeler code
72789
Product ID
72789-292_40bad50c-2986-1150-e063-6394a90a23a2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Spironolactone
Dosage form
TABLET, COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA040750
Marketing category
ANDA
Marketing start
2021-01-04
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
72789-292-30Spironolactone30 in 1 BOTTLE, PLASTICTABLET, COATED3010
72789-292-60Spironolactone60 in 1 BOTTLE, PLASTICTABLET, COATED6010
72789-292-82Spironolactone500 in 1 BOTTLE, PLASTICTABLET, COATED50010
72789-292-90Spironolactone90 in 1 BOTTLE, PLASTICTABLET, COATED9010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-292SPIRONOLACTONE TABLET, COATED [PD-RX PHARMACEUTICALS, INC.]9Current NDC, Legacy NDC, 4 package rows20241210_8cbe2215-744c-438a-b3d6-b7d6ae769231.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198222spironolactone 100 MG Oral TabletPSN8cbe2215-744c-438a-b3d6-b7d6ae76923110
198222spironolactone 100 MG Oral TabletSCD8cbe2215-744c-438a-b3d6-b7d6ae76923110

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72789-292-307278902923030 TABLET, COATED in 1 BOTTLE, PLASTIC (72789-292-30) 2022-12-080000-00-00NoNoCurrent
72789-292-607278902926060 TABLET, COATED in 1 BOTTLE, PLASTIC (72789-292-60) 2022-12-080000-00-00NoNoCurrent
72789-292-8272789029282500 TABLET, COATED in 1 BOTTLE, PLASTIC (72789-292-82) 2022-12-080000-00-00NoNoCurrent
72789-292-907278902929090 TABLET, COATED in 1 BOTTLE, PLASTIC (72789-292-90) 2022-12-080000-00-00NoNoCurrent