Spironolactone

Product NDC
68788-7258
11-digit product format
687887258
Labeler code
68788
Product ID
68788-7258_9eebf4f4-19d6-4f4a-8282-1f9436877d0b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Spironolactone
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA091426
Marketing category
ANDA
Marketing start
2018-09-11
Marketing end
0000-00-00
Substance
SPIRONOLACTONE
Active strength
50 mg/1
Pharmacologic classes
Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7258-3EA - Each68788-725827878ed8-0e74-494d-b33a-5b174afea84512018-11-06
68788-7258-6EA - Each68788-7258d53b2b52-2998-4d3c-a2ad-a087e986642d12018-11-06
68788-7258-9EA - Each68788-7258173329c9-92de-448b-90ec-b1db5001ce5912018-11-06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7258-36878872580330 TABLET in 1 BOTTLE (68788-7258-3) 30 tablet2018-09-110000-00-00NoNoCurrent
68788-7258-66878872580660 TABLET in 1 BOTTLE (68788-7258-6) 60 tablet2018-09-110000-00-00NoNoCurrent
68788-7258-96878872580990 TABLET in 1 BOTTLE (68788-7258-9) 90 tablet2018-09-110000-00-00NoNoCurrent