Lovastatin

Product NDC
68788-8287
11-digit product format
687888287
Labeler code
68788
Product ID
68788-8287_89cfb920-9cab-43b2-a6d9-33e6e62fbeb5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lovastatin
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA078296
Marketing category
ANDA
Marketing start
2022-11-17
Substance
LOVASTATIN
Active strength
10 mg/1
Pharmacologic classes
HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dc9a5fb6-14e2-1cc8-a567-a781fd1f0212Product name120140508
f1ae760e-e8ec-b0b4-fb1b-2db7c49fcec5Product name120140508
fecc3d5d-ff9a-60ad-1a3a-6cb9b21df758Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-8287-1Lovastatin100 in 1 BOTTLETABLET1004
68788-8287-3Lovastatin30 in 1 BOTTLETABLET304
68788-8287-6Lovastatin60 in 1 BOTTLETABLET604
68788-8287-9Lovastatin90 in 1 BOTTLETABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8287-1EA - Each68788-8287c422810e-865f-46a0-bb4f-17790e47bcc612023-01-09
68788-8287-3EA - Each68788-8287d29d95b0-9d02-4358-95ae-1bbed07fd96112023-01-09
68788-8287-6EA - Each68788-82870b89cf29-c3e7-43e7-9c78-c6f2385da2e212023-01-09
68788-8287-9EA - Each68788-828794339418-7af5-4689-9dc6-346cfce0081312023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8287LOVASTATIN TABLET [PREFERRED PHARMACEUTICALS, INC.]3Current NDC, Legacy NDC, 4 package rows20240703_8a77e539-a31e-43a4-a53e-a4204aa38558.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197903lovastatin 10 MG Oral TabletPSN8a77e539-a31e-43a4-a53e-a4204aa385584
197903lovastatin 10 MG Oral TabletSCD8a77e539-a31e-43a4-a53e-a4204aa385584

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-8287-168788828701100 TABLET in 1 BOTTLE (68788-8287-1) 100 tablet2022-11-170000-00-00NoNoCurrent
68788-8287-36878882870330 TABLET in 1 BOTTLE (68788-8287-3) 30 tablet2022-11-170000-00-00NoNoCurrent
68788-8287-66878882870660 TABLET in 1 BOTTLE (68788-8287-6) 60 tablet2022-11-170000-00-00NoNoCurrent
68788-8287-96878882870990 TABLET in 1 BOTTLE (68788-8287-9) 90 tablet2022-11-170000-00-00NoNoCurrent