Lovastatin

Product NDC
43353-995
11-digit product format
433530995
Labeler code
43353
Product ID
43353-995_ca06eda8-31b3-4f42-a57a-630656336e73
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lovastatin
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA075828
Marketing category
ANDA
Marketing start
2014-06-24
Marketing end
0000-00-00
Substance
LOVASTATIN
Active strength
40 mg/1
Pharmacologic classes
HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-995-45EA - Each43353-99565b80345-896b-4545-8e5d-80deacf21ec112016-11-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-995LOVASTATIN TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC20160708_0e700413-6ee6-454b-927a-ff5daa97477c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43353-995-454335309954545 TABLET in 1 BOTTLE (43353-995-45) 45 tablet2015-02-130000-00-00NoNoCurrent