Spironolactone

Product NDC
50090-3916
11-digit product format
500903916
Labeler code
50090
Product ID
50090-3916_38c470de-85af-417b-8357-f4597e30fd4f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
spironolactone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA203512
Marketing category
ANDA
Marketing start
2017-06-02
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
50090-3916-0EA - Each50090-391651e6ca3b-df72-481d-9c8a-3dd3c7bb669a12021-12-08
50090-3916-1EA - Each50090-39169f2676fa-91e1-42b1-8c52-f827f3b5084612024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3916SPIRONOLACTONE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]11Legacy NDC20240126_26a3a364-9296-4d68-8871-af01809b96bd.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-3916-05009039160090 TABLET, FILM COATED in 1 BOTTLE (50090-3916-0) 2018-12-060000-00-00NoNoCurrent
50090-3916-15009039160130 TABLET, FILM COATED in 1 BOTTLE (50090-3916-1) 2018-12-060000-00-00NoNoCurrent