FDA.reportPublic FDA data

LOVASTATIN

Product NDC
61919-941
11-digit product format
619190941
Labeler code
61919
Product ID
61919-941_f21620a9-ccb5-d6aa-e053-2a95a90a7ced
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LOVASTATIN
Dosage form
TABLET
Route
ORAL
Labeler
Direct_Rx
Application
ANDA075991
Marketing category
ANDA
Marketing start
2014-01-01
Marketing end
0000-00-00
Substance
LOVASTATIN
Active strength
40 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
61919-941-902025-01-30C16284748780-12cef2736-8542-d83d-e063-dadaa90ab31fLOVASTATIN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-941-90LOVASTATIN90 in 1 BOTTLETABLET905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-941-90EA - Each61919-9413e135877-f2f7-4181-bf9b-565f2fbaa34712015-04-03

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
61919-941LOVASTATIN TABLET [DIRECT_RX]5Legacy NDC, 1 package rows20230113_8e5a0177-4804-4638-ad82-c8877653b232.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197905lovastatin 40 MG Oral TabletPSN8e5a0177-4804-4638-ad82-c8877653b2325
197905lovastatin 40 MG Oral TabletSCD8e5a0177-4804-4638-ad82-c8877653b2325

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-941-906191909419090 TABLET in 1 BOTTLE (61919-941-90) 90 tablet2019-09-180000-00-00NoNoCurrent