SPIRONOLACTONE

Product NDC
71335-2301
11-digit product format
713352301
Labeler code
71335
Product ID
71335-2301_844e154e-2692-4ed3-af1e-08e5a86cd297
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SPIRONOLACTONE
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA089424
Marketing category
ANDA
Marketing start
1986-07-23
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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
27O7W4T232SPIRONOLACTONE52-01-7SPIRONOLACTONE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2301-1713352301011000 TABLET in 1 BOTTLE, PLASTIC (71335-2301-1) 1000 tablet2023-12-01NoNoHistorical
71335-2301-271335230102500 TABLET in 1 BOTTLE, PLASTIC (71335-2301-2) 500 tablet2023-12-01NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
SPIRONOLACTONEBryant Ranch Prepack2026-05-15HUMAN PRESCRIPTION DRUG LABEL101