SPIRONOLACTONE

Product NDC
71335-2887
11-digit product format
713352887
Labeler code
71335
Product ID
71335-2887_587353ec-0515-4398-83cd-14abc4f49ae9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SPIRONOLACTONE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA089424
Marketing category
ANDA
Marketing start
1986-07-23
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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
27O7W4T232SPIRONOLACTONE52-01-7SPIRONOLACTONE

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-2887-171335288701100 TABLET, FILM COATED in 1 BOTTLE (71335-2887-1) 2025-10-28NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
SPIRONOLACTONEBryant Ranch Prepack2025-10-28HUMAN PRESCRIPTION DRUG LABEL100