Spironolactone

Product NDC
71205-147
11-digit product format
712050147
Labeler code
71205
Product ID
71205-147_5857334b-cd0a-47c8-ba29-b8ba367162fa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
spironolactone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA203512
Marketing category
ANDA
Marketing start
2017-06-02
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
Rxcui198222, 198223, 313096

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
71205-147-30Spironolactone30 in 1 BOTTLETABLET, FILM COATED305
71205-147-60Spironolactone60 in 1 BOTTLETABLET, FILM COATED605
71205-147-90Spironolactone90 in 1 BOTTLETABLET, FILM COATED905

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-147SPIRONOLACTONE TABLET, FILM COATED [PROFICIENT RX LP]5Current NDC, Legacy NDC, 3 package rows20230430_dffac5dc-a111-4095-a96c-54cc5c3866e5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198222spironolactone 100 MG Oral TabletPSNdffac5dc-a111-4095-a96c-54cc5c3866e55
313096spironolactone 25 MG Oral TabletPSNdffac5dc-a111-4095-a96c-54cc5c3866e55
198223spironolactone 50 MG Oral TabletPSNdffac5dc-a111-4095-a96c-54cc5c3866e55
198222spironolactone 100 MG Oral TabletSCDdffac5dc-a111-4095-a96c-54cc5c3866e55
313096spironolactone 25 MG Oral TabletSCDdffac5dc-a111-4095-a96c-54cc5c3866e55
198223spironolactone 50 MG Oral TabletSCDdffac5dc-a111-4095-a96c-54cc5c3866e55

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-147-307120501473030 TABLET, FILM COATED in 1 BOTTLE (71205-147-30) 2018-11-010000-00-00NoNoCurrent
71205-147-607120501476060 TABLET, FILM COATED in 1 BOTTLE (71205-147-60) 2018-11-010000-00-00NoNoCurrent
71205-147-907120501479090 TABLET, FILM COATED in 1 BOTTLE (71205-147-90) 2018-11-010000-00-00NoNoCurrent