FDA.reportPublic FDA data

Lovastatin

Product NDC
68001-314
11-digit product format
680010314
Labeler code
68001
Product ID
68001-314_26682060-6c21-5cd7-e063-6394a90ab4dd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lovastatin
Dosage form
TABLET
Route
ORAL
Labeler
BluePoint Laboratories
Application
ANDA078296
Marketing category
ANDA
Marketing start
2007-11-01
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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LOVASTATIN10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9LHU78OQFD
Rxcui197903, 197904, 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
68001-314-00Lovastatin100 in 1 BOTTLETABLET1008
68001-314-08Lovastatin1000 in 1 BOTTLETABLET10008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-314-00EA - Each68001-3149e84e273-6c29-464b-8926-aca12306a23f12017-10-13
68001-314-08EA - Each68001-314d6535faf-c0d0-4760-b666-f5cb235ec67e12017-10-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68001-314LOVASTATIN TABLET [BLUEPOINT LABORATORIES]7Current NDC, Legacy NDC, 2 package rows20241116_7b86160d-74a9-4774-b5b3-5641e686991f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197903lovastatin 10 MG Oral TabletPSN7b86160d-74a9-4774-b5b3-5641e686991f8
197904lovastatin 20 MG Oral TabletPSN7b86160d-74a9-4774-b5b3-5641e686991f8
197905lovastatin 40 MG Oral TabletPSN7b86160d-74a9-4774-b5b3-5641e686991f8
197903lovastatin 10 MG Oral TabletSCD7b86160d-74a9-4774-b5b3-5641e686991f8
197904lovastatin 20 MG Oral TabletSCD7b86160d-74a9-4774-b5b3-5641e686991f8
197905lovastatin 40 MG Oral TabletSCD7b86160d-74a9-4774-b5b3-5641e686991f8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68001-314-0068001031400100 TABLET in 1 BOTTLE (68001-314-00) 100 tablet2017-02-070000-00-00NoNoCurrent
68001-314-08680010314081000 TABLET in 1 BOTTLE (68001-314-08) 1000 tablet2017-02-070000-00-00NoNoCurrent