Spironolactone

Product NDC
70518-0455
11-digit product format
705180455
Labeler code
70518
Product ID
70518-0455_ed10727d-733e-342e-e053-2a95a90ae1e8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Spironolactone
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA091426
Marketing category
ANDA
Marketing start
2017-04-24
Marketing end
0000-00-00
Substance
SPIRONOLACTONE
Active strength
25 mg/1
Pharmacologic classes
Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-0455SPIRONOLACTONE TABLET [REMEDYREPACK INC.]15Legacy NDC20250427_71a0b3ea-7efc-4c08-9133-88b4ecc5840b.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-0455-27051804550230 TABLET in 1 BLISTER PACK (70518-0455-2) 30 tablet2020-07-130000-00-00NoNoCurrent