Spironolactone

Product NDC
68788-7019
11-digit product format
687887019
Labeler code
68788
Product ID
68788-7019_a551b8ad-e3f9-46a5-8920-b3fbae6b9e00
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
spironolactone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA203512
Marketing category
ANDA
Marketing start
2017-10-11
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
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7019SPIRONOLACTONE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]8Legacy NDC20240814_1c4c5aed-5ee4-4b85-954b-9e80551985c1.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-7019-36878870190330 TABLET, FILM COATED in 1 BOTTLE (68788-7019-3) 2017-10-110000-00-00NoNoCurrent
68788-7019-66878870190660 TABLET, FILM COATED in 1 BOTTLE (68788-7019-6) 2017-10-110000-00-00NoNoCurrent
68788-7019-96878870190990 TABLET, FILM COATED in 1 BOTTLE (68788-7019-9) 2017-10-110000-00-00NoNoCurrent