FDA.reportPublic FDA data

LOVASTATIN

Product NDC
61919-547
11-digit product format
619190547
Labeler code
61919
Product ID
61919-547_b8b65187-6bbb-18ef-e053-2a95a90aa01f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LOVASTATIN
Dosage form
TABLET
Route
ORAL
Labeler
Direct_Rx
Application
ANDA075991
Marketing category
ANDA
Marketing start
2019-08-21
Marketing end
0000-00-00
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
2022-12-31
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
61919-547-712025-01-30C16284748780-12cef2736-a3a9-d83d-e063-dadaa90ab31fLOVASTATIN
61919-547-302024-01-30C16284748780-19d75b9d0-b95f-f424-e053-dadaa90a57ceLOVASTATIN
61919-547-902024-01-30C16284748780-19d75b9d0-b95f-f424-e053-dadaa90a57ceLOVASTATIN
61919-547-302021-01-12C16284748780-19d75b9d0-b95f-f424-e053-dadaa90a57ceLOVASTATIN
61919-547-902021-01-12C16284748780-19d75b9d0-b95f-f424-e053-dadaa90a57ceLOVASTATIN
61919-547-302020-01-31C16284748780-19d75b9d0-b95f-f424-e053-dadaa90a57ceLOVASTATIN
61919-547-902020-01-31C16284748780-19d75b9d0-b95f-f424-e053-dadaa90a57ceLOVASTATIN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-547-30LOVASTATIN30 in 1 BOTTLETABLET306
61919-547-90LOVASTATIN90 in 1 BOTTLETABLET906
61919-547-71LOVASTATIN100 in 1 BOTTLETABLET1004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-547-30EA - Each61919-5473fc0b862-6252-4178-a98f-9160814a27e412016-11-08
61919-547-71EA - Each61919-547b9016103-fe57-4950-b119-5b48fbd105c712019-09-05
61919-547-90EA - Each61919-547677d1215-032c-4344-8307-ca8a185d287612015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LOVASTATINACTIVE INGREDIENT9LHU78OQFDLOVASTATIN TABLET [DIRECT RX]1
LOVASTATINACTIVE MOIETY9LHU78OQFDLOVASTATIN TABLET [DIRECT RX]1
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2ULOVASTATIN TABLET [DIRECT RX]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULOVASTATIN TABLET [DIRECT RX]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLOVASTATIN TABLET [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LOVASTATIN TABLET [DIRECT RX]1
POLOXAMER 188INACTIVE INGREDIENTLQA7B6G8JGLOVASTATIN TABLET [DIRECT RX]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2LOVASTATIN TABLET [DIRECT RX]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLOVASTATIN TABLET [DIRECT RX]1
TALCINACTIVE INGREDIENT7SEV7J4R1ULOVASTATIN TABLET [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-547LOVASTATIN TABLET [DIRECT RX]6Legacy NDC, 2 package rows20210113_b2f17323-2e08-462a-9a91-42f22bcaf53c.zip
61919-547LOVASTATIN TABLET [DIRECT_RX]4Legacy NDC, 1 package rows20230510_90a27c1d-3f44-e51e-e053-2a95a90a9e7b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197904lovastatin 20 MG Oral TabletPSNb2f17323-2e08-462a-9a91-42f22bcaf53c6
197904lovastatin 20 MG Oral TabletSCDb2f17323-2e08-462a-9a91-42f22bcaf53c6
197904lovastatin 20 MG Oral TabletPSN90a27c1d-3f44-e51e-e053-2a95a90a9e7b4
197904lovastatin 20 MG Oral TabletSCD90a27c1d-3f44-e51e-e053-2a95a90a9e7b4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-547-306191905473030 TABLET in 1 BOTTLE (61919-547-30) 30 tablet2014-01-010000-00-00NoNoCurrent
61919-547-7161919054771100 TABLET in 1 BOTTLE (61919-547-71) 100 tablet2019-08-210000-00-00NoNoCurrent
61919-547-906191905479090 TABLET in 1 BOTTLE (61919-547-90) 90 tablet2015-11-090000-00-00NoNoCurrent