FDA.reportPublic FDA data

Spironolactone

Product NDC
72789-290
11-digit product format
727890290
Labeler code
72789
Product ID
72789-290_525a6d19-36b9-ca74-e063-6294a90a03cb
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
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
72789-290-30Spironolactone30 in 1 BOTTLE, PLASTICTABLET, COATED3012
72789-290-60Spironolactone60 in 1 BOTTLE, PLASTICTABLET, COATED6012
72789-290-90Spironolactone90 in 1 BOTTLE, PLASTICTABLET, COATED9012
72789-290-95Spironolactone1000 in 1 BOTTLE, PLASTICTABLET, COATED100012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-290-30EA - Each72789-2908165f6b2-ea1b-4985-8a2c-470acee2b2d512023-01-09
72789-290-60EA - Each72789-290c5e7caa3-c025-4a5c-96d9-c96e1f62ecfd12023-01-09
72789-290-90EA - Each72789-290a0418408-fa5b-450b-bcf8-144c5588055b12023-01-09
72789-290-95EA - Each72789-29033b14b27-5d5b-48de-a440-132dae3188a012023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-290SPIRONOLACTONE TABLET, COATED [PD-RX PHARMACEUTICALS, INC.]11Current NDC, Legacy NDC, 4 package rows20250124_73564b3d-8ede-4008-b75c-1277153b5bb6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313096spironolactone 25 MG Oral TabletPSN73564b3d-8ede-4008-b75c-1277153b5bb612
313096spironolactone 25 MG Oral TabletSCD73564b3d-8ede-4008-b75c-1277153b5bb612

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72789-290-307278902903030 TABLET, COATED in 1 BOTTLE, PLASTIC (72789-290-30) 2022-12-080000-00-00NoNoCurrent
72789-290-607278902906060 TABLET, COATED in 1 BOTTLE, PLASTIC (72789-290-60) 2022-12-080000-00-00NoNoCurrent
72789-290-907278902909090 TABLET, COATED in 1 BOTTLE, PLASTIC (72789-290-90) 2022-12-080000-00-00NoNoCurrent
72789-290-95727890290951000 TABLET, COATED in 1 BOTTLE, PLASTIC (72789-290-95) 2022-12-120000-00-00NoNoCurrent