lovastatin

Product NDC
53489-607
11-digit product format
534890607
Labeler code
53489
Product ID
53489-607_36f83432-6257-4cda-9902-510ec4b0975c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lovastatin
Dosage form
TABLET
Route
ORAL
Labeler
Mutual Pharmaceutical Company, Inc.
Application
ANDA077520
Marketing category
ANDA
Marketing start
2006-04-14
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
E
Listing certified through
2017-12-31
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53489-607-01lovastatin100 in 1 BOTTLE, PLASTICTABLET1005
53489-607-03lovastatin250 in 1 BOTTLE, PLASTICTABLET2505
53489-607-05lovastatin500 in 1 BOTTLE, PLASTICTABLET5005
53489-607-06lovastatin60 in 1 BOTTLE, PLASTICTABLET605
53489-607-07lovastatin30 in 1 BOTTLE, PLASTICTABLET305
53489-607-10lovastatin1000 in 1 BOTTLE, PLASTICTABLET10005

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
lovastatinACTIVE INGREDIENT9LHU78OQFDLOVASTATIN TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]5
lovastatinACTIVE MOIETY9LHU78OQFDLOVASTATIN TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]5
aluminum oxideINACTIVE INGREDIENTLMI26O6933LOVASTATIN TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]5
butylated hydroxyanisoleINACTIVE INGREDIENTREK4960K2ULOVASTATIN TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]5
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61ULOVASTATIN TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]5
FD&C blue no. 2INACTIVE INGREDIENTL06K8R7DQKLOVASTATIN TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]5
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XLOVASTATIN TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]5
magnesium stearateINACTIVE INGREDIENT70097M6I30LOVASTATIN TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]5
starch, cornINACTIVE INGREDIENTO8232NY3SJLOVASTATIN TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53489-607LOVASTATIN TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]5Legacy NDC, 6 package rows20130105_caf7c3af-8256-4557-af40-e8143e9af9f1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197903lovastatin 10 MG Oral TabletPSNcaf7c3af-8256-4557-af40-e8143e9af9f15
197904lovastatin 20 MG Oral TabletPSNcaf7c3af-8256-4557-af40-e8143e9af9f15
197905lovastatin 40 MG Oral TabletPSNcaf7c3af-8256-4557-af40-e8143e9af9f15
197903lovastatin 10 MG Oral TabletSCDcaf7c3af-8256-4557-af40-e8143e9af9f15
197904lovastatin 20 MG Oral TabletSCDcaf7c3af-8256-4557-af40-e8143e9af9f15
197905lovastatin 40 MG Oral TabletSCDcaf7c3af-8256-4557-af40-e8143e9af9f15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53489-607-0153489060701100 in 1 BOTTLE, PLASTICHistorical
53489-607-0353489060703250 in 1 BOTTLE, PLASTICHistorical
53489-607-0553489060705500 in 1 BOTTLE, PLASTICHistorical
53489-607-065348906070660 in 1 BOTTLE, PLASTICHistorical
53489-607-075348906070730 in 1 BOTTLE, PLASTICHistorical
53489-607-10534890607101000 in 1 BOTTLE, PLASTICHistorical