Lovastatin

Product NDC
63629-1018
11-digit product format
636291018
Labeler code
63629
Product ID
63629-1018_67bf8a65-3ac2-4e9c-a655-51f0717de716
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lovastatin
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA075991
Marketing category
ANDA
Marketing start
2002-11-25
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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LOVASTATIN10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9LHU78OQFD
Rxcui197903

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63629-1018-02020-07-10C16284748780-19d75b9d1-1434-f424-e053-dadaa90a57ceLovastatin Tablet USP Revision M
63629-1018-12020-07-10C16284748780-19d75b9d1-1434-f424-e053-dadaa90a57ceLovastatin Tablet USP Revision M
63629-1018-22020-07-10C16284748780-19d75b9d1-1434-f424-e053-dadaa90a57ceLovastatin Tablet USP Revision M
63629-1018-32020-07-10C16284748780-19d75b9d1-1434-f424-e053-dadaa90a57ceLovastatin Tablet USP Revision M
63629-1018-42020-07-10C16284748780-19d75b9d1-1434-f424-e053-dadaa90a57ceLovastatin Tablet USP Revision M
63629-1018-52020-07-10C16284748780-19d75b9d1-1434-f424-e053-dadaa90a57ceLovastatin Tablet USP Revision M
63629-1018-62020-07-10C16284748780-19d75b9d1-1434-f424-e053-dadaa90a57ceLovastatin Tablet USP Revision M
63629-1018-82020-07-10C16284748780-19d75b9d1-1434-f424-e053-dadaa90a57ceLovastatin Tablet USP Revision M
63629-1018-92020-07-10C16284748780-19d75b9d1-1434-f424-e053-dadaa90a57ceLovastatin Tablet USP Revision M
63629-1018-02020-01-31C16284748780-19d75b9d1-1434-f424-e053-dadaa90a57ceLovastatin Tablet USP Revision M
63629-1018-12020-01-31C16284748780-19d75b9d1-1434-f424-e053-dadaa90a57ceLovastatin Tablet USP Revision M
63629-1018-22020-01-31C16284748780-19d75b9d1-1434-f424-e053-dadaa90a57ceLovastatin Tablet USP Revision M
63629-1018-32020-01-31C16284748780-19d75b9d1-1434-f424-e053-dadaa90a57ceLovastatin Tablet USP Revision M
63629-1018-42020-01-31C16284748780-19d75b9d1-1434-f424-e053-dadaa90a57ceLovastatin Tablet USP Revision M
63629-1018-52020-01-31C16284748780-19d75b9d1-1434-f424-e053-dadaa90a57ceLovastatin Tablet USP Revision M
63629-1018-62020-01-31C16284748780-19d75b9d1-1434-f424-e053-dadaa90a57ceLovastatin Tablet USP Revision M
63629-1018-82020-01-31C16284748780-19d75b9d1-1434-f424-e053-dadaa90a57ceLovastatin Tablet USP Revision M
63629-1018-92020-01-31C16284748780-19d75b9d1-1434-f424-e053-dadaa90a57ceLovastatin Tablet USP Revision M

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-1018-0Lovastatin1000 in 1 BOTTLETABLET100014
63629-1018-1Lovastatin100 in 1 BOTTLETABLET10014
63629-1018-2Lovastatin30 in 1 BOTTLETABLET3014
63629-1018-3Lovastatin300 in 1 BOTTLETABLET30014
63629-1018-4Lovastatin120 in 1 BOTTLETABLET12014
63629-1018-5Lovastatin500 in 1 BOTTLETABLET50014
63629-1018-6Lovastatin60 in 1 BOTTLETABLET6014
63629-1018-8Lovastatin800 in 1 BOTTLETABLET80014
63629-1018-9Lovastatin90 in 1 BOTTLETABLET9014

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-1018LOVASTATIN TABLET [BRYANT RANCH PREPACK]14Current NDC, Legacy NDC, 9 package rows20240913_c871a6a7-67a4-4ac1-b102-3f1604625c7d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197903lovastatin 10 MG Oral TabletPSNc871a6a7-67a4-4ac1-b102-3f1604625c7d14
197903lovastatin 10 MG Oral TabletSCDc871a6a7-67a4-4ac1-b102-3f1604625c7d14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-1018-0636291018001000 TABLET in 1 BOTTLE (63629-1018-0) 1000 tablet2024-08-140000-00-00NoNoCurrent
63629-1018-163629101801100 TABLET in 1 BOTTLE (63629-1018-1) 100 tablet2024-08-140000-00-00NoNoCurrent
63629-1018-26362910180230 TABLET in 1 BOTTLE (63629-1018-2) 30 tablet2024-08-140000-00-00NoNoCurrent
63629-1018-363629101803300 TABLET in 1 BOTTLE (63629-1018-3) 300 tablet2024-08-140000-00-00NoNoCurrent
63629-1018-463629101804120 TABLET in 1 BOTTLE (63629-1018-4) 120 tablet2019-12-160000-00-00NoNoCurrent
63629-1018-563629101805500 TABLET in 1 BOTTLE (63629-1018-5) 500 tablet2019-12-100000-00-00NoNoCurrent
63629-1018-66362910180660 TABLET in 1 BOTTLE (63629-1018-6) 60 tablet2024-08-140000-00-00NoNoCurrent
63629-1018-863629101808800 TABLET in 1 BOTTLE (63629-1018-8) 800 tablet2024-08-140000-00-00NoNoCurrent
63629-1018-96362910180990 TABLET in 1 BOTTLE (63629-1018-9) 90 tablet2024-08-140000-00-00NoNoCurrent