LOVASTATIN

Product NDC
61919-311
11-digit product format
619190311
Labeler code
61919
Product ID
61919-311_f2122b79-79b3-45e0-e053-2995a90a3d7c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LOVASTATIN
Dosage form
TABLET
Route
ORAL
Labeler
Direct Rx
Application
ANDA078296
Marketing category
ANDA
Marketing start
2014-01-01
Marketing end
0000-00-00
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
2024-12-31
Current FDA listing
Historical FDA.report record

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
61919-311-302025-01-30C16284748780-12cef2736-60d4-d83d-e063-dadaa90ab31fLOVASTATIN
61919-311-602025-01-30C16284748780-12cef2736-60d4-d83d-e063-dadaa90ab31fLOVASTATIN
61919-311-902025-01-30C16284748780-12cef2736-60d4-d83d-e063-dadaa90ab31fLOVASTATIN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-311-30LOVASTATIN30 in 1 BOTTLETABLET307
61919-311-60LOVASTATIN60 in 1 BOTTLETABLET607
61919-311-90LOVASTATIN90 in 1 BOTTLETABLET907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-311-90EA - Each61919-3111508e8de-ba23-4d44-8c97-5524192edee912014-12-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LOVASTATINACTIVE INGREDIENT9LHU78OQFDLOVASTATIN TABLET [DIRECT RX]2
LOVASTATINACTIVE MOIETY9LHU78OQFDLOVASTATIN TABLET [DIRECT RX]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKLOVASTATIN TABLET [DIRECT RX]2
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2ULOVASTATIN TABLET [DIRECT RX]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULOVASTATIN TABLET [DIRECT RX]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GLOVASTATIN TABLET [DIRECT RX]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKLOVASTATIN TABLET [DIRECT RX]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLOVASTATIN TABLET [DIRECT RX]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LOVASTATIN TABLET [DIRECT RX]2
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJLOVASTATIN TABLET [DIRECT RX]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-311LOVASTATIN TABLET [DIRECT RX]7Legacy NDC, 3 package rows20230419_e16b6922-8ebc-4ee6-b70e-31834e61a540.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197903lovastatin 10 MG Oral TabletPSNe16b6922-8ebc-4ee6-b70e-31834e61a5407
197903lovastatin 10 MG Oral TabletSCDe16b6922-8ebc-4ee6-b70e-31834e61a5407

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-311-306191903113030 TABLET in 1 BOTTLE (61919-311-30) 30 tablet2015-01-010000-00-00NoNoCurrent
61919-311-606191903116060 TABLET in 1 BOTTLE (61919-311-60) 60 tablet2015-12-040000-00-00NoNoCurrent
61919-311-906191903119090 TABLET in 1 BOTTLE (61919-311-90) 90 tablet2014-01-010000-00-00NoNoCurrent