Spironolactone

Product NDC
71610-102
11-digit product format
716100102
Labeler code
71610
Product ID
71610-102_c9e366cc-e9b4-4e14-8c40-8daf2fe265ad
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Spironolactone
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA091426
Marketing category
ANDA
Marketing start
2010-08-02
Substance
SPIRONOLACTONE
Active strength
25 mg/1
Pharmacologic classes
Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
27O7W4T232SPIRONOLACTONE52-01-7SPIRONOLACTONE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71610-102-607161001026090 TABLET in 1 BOTTLE (71610-102-60) 90 tablet2018-07-26NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
SpironolactoneAphena Pharma Solutions - Tennessee, LLC2018-08-08HUMAN PRESCRIPTION DRUG LABEL1