Lovastatin

Product NDC
68645-566
11-digit product format
686450566
Labeler code
68645
Product ID
68645-566_4cc241a1-d876-0439-e063-6394a90a2733
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lovastatin
Dosage form
TABLET
Route
ORAL
Labeler
Legacy Pharmaceutical Packaging, LLC
Application
ANDA078296
Marketing category
ANDA
Marketing start
2007-11-01
Substance
LOVASTATIN
Active strength
20 mg/1
Pharmacologic classes
HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Lovastatin
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LOVASTATIN20 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
68645-566-90Lovastatin90 in 1 BOTTLETABLET909

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68645-566LOVASTATIN TABLET [LEGACY PHARMACEUTICAL PACKAGING, LLC]8Current NDC, Legacy NDC, 1 package rows20250418_a4f02fa1-3281-46fa-bd52-323e2644b6f8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197904lovastatin 20 MG Oral TabletPSNa4f02fa1-3281-46fa-bd52-323e2644b6f89
197905lovastatin 40 MG Oral TabletPSNa4f02fa1-3281-46fa-bd52-323e2644b6f89
197904lovastatin 20 MG Oral TabletSCDa4f02fa1-3281-46fa-bd52-323e2644b6f89
197905lovastatin 40 MG Oral TabletSCDa4f02fa1-3281-46fa-bd52-323e2644b6f89

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68645-566-906864505669090 TABLET in 1 BOTTLE (68645-566-90) 90 tablet2007-11-010000-00-00NoNoCurrent