spironolactone

Product NDC
70518-4470
11-digit product format
705184470
Labeler code
70518
Product ID
70518-4470_3e5e0ca1-c66f-df74-e063-6394a90a7528
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
spironolactone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA205936
Marketing category
ANDA
Marketing start
2025-09-08
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
70518-4470-070518447000100 POUCH in 1 BOX (70518-4470-0) / 1 TABLET, FILM COATED in 1 POUCH (70518-4470-1) 100 pouch2025-09-08NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
spironolactoneREMEDYREPACK INC.2025-09-09HUMAN PRESCRIPTION DRUG LABEL1