Spironolactone

Product NDC
50090-1308
11-digit product format
500901308
Labeler code
50090
Product ID
50090-1308_1c250b12-f8fe-4891-9bf2-6792d71f7c77
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Spironolactone
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA091426
Marketing category
ANDA
Marketing start
2010-08-02
Marketing end
0000-00-00
Substance
SPIRONOLACTONE
Active strength
100 mg/1
Pharmacologic classes
Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1308-0EA - Each50090-130821475bdc-2090-4a8c-bab4-e10fd590502f12018-11-06
50090-1308-1EA - Each50090-1308cdec23c3-4185-4235-bb2b-9345517bb56312018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1308SPIRONOLACTONE TABLET [A-S MEDICATION SOLUTIONS]37Legacy NDC20240906_e0ec74d4-4040-4eb2-b820-42e385e960af.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-1308-05009013080090 TABLET in 1 BOTTLE (50090-1308-0) 90 tablet2014-11-280000-00-00NoNoCurrent
50090-1308-15009013080130 TABLET in 1 BOTTLE (50090-1308-1) 30 tablet2014-11-280000-00-00NoNoCurrent