Lovastatin

Product NDC
0615-8152
11-digit product format
006158152
Labeler code
0615
Product ID
0615-8152_5b45e9ad-8c7f-43d0-8989-469795156f90
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lovastatin
Dosage form
TABLET
Route
ORAL
Labeler
NCS HealthCare of KY, LLC dba Vangard Labs
Application
ANDA078296
Marketing category
ANDA
Marketing start
2018-07-10
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Lovastatin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LOVASTATIN40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9LHU78OQFD
Rxcui197904, 197905

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
0615-8152-39Lovastatin30 in 1 BLISTER PACKTABLET3015

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0615-8152LOVASTATIN TABLET [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS]15Current NDC, Legacy NDC, 1 package rows20240806_3af47e72-082d-42ad-bde0-294f8101b45c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197904lovastatin 20 MG Oral TabletPSN3af47e72-082d-42ad-bde0-294f8101b45c15
197905lovastatin 40 MG Oral TabletPSN3af47e72-082d-42ad-bde0-294f8101b45c15
197904lovastatin 20 MG Oral TabletSCD3af47e72-082d-42ad-bde0-294f8101b45c15
197905lovastatin 40 MG Oral TabletSCD3af47e72-082d-42ad-bde0-294f8101b45c15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0615-8152-390061581523930 TABLET in 1 BLISTER PACK (0615-8152-39) 30 tablet2018-07-100000-00-00NoNoCurrent