Spironolactone

Product NDC
63187-861
11-digit product format
631870861
Labeler code
63187
Product ID
63187-861_d5bfc979-a820-4d06-ab41-9ccbaf28a914
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
spironolactone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA203253
Marketing category
ANDA
Marketing start
2013-02-01
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
63187-861-306318708613030 TABLET, FILM COATED in 1 BOTTLE (63187-861-30) 2017-06-01NoNoHistorical
63187-861-606318708616060 TABLET, FILM COATED in 1 BOTTLE (63187-861-60) 2017-06-01NoNoHistorical
63187-861-906318708619090 TABLET, FILM COATED in 1 BOTTLE (63187-861-90) 2017-06-01NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Spironolactone Tablets, USPProficient Rx LP2019-11-01HUMAN PRESCRIPTION DRUG LABEL3