FDA.reportPublic FDA data

Lovastatin

Product NDC
33261-549
11-digit product format
332610549
Labeler code
33261
Product ID
33261-549_397bf662-ca3a-44ce-a21f-745cf71e15de
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lovastatin
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA075991
Marketing category
ANDA
Marketing start
2002-11-25
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
2019-12-31
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
33261-549-902020-01-31C16284748780-19d75b9d1-24ae-f424-e053-dadaa90a57ceLovastatin Tablet USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-549-90Lovastatin90 in 1 BOTTLE, PLASTICTABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-549-90EA - Each33261-549de45bb73-395e-4e29-bdf4-20b73c36a0e412015-10-02

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-549LOVASTATIN TABLET [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 1 package rows20140128_46fe2a49-2ce1-4ddf-bf06-6958b917219e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197903lovastatin 10 MG Oral TabletPSN46fe2a49-2ce1-4ddf-bf06-6958b917219e1
197904lovastatin 20 MG Oral TabletPSN46fe2a49-2ce1-4ddf-bf06-6958b917219e1
197905lovastatin 40 MG Oral TabletPSN46fe2a49-2ce1-4ddf-bf06-6958b917219e1
197903lovastatin 10 MG Oral TabletSCD46fe2a49-2ce1-4ddf-bf06-6958b917219e1
197904lovastatin 20 MG Oral TabletSCD46fe2a49-2ce1-4ddf-bf06-6958b917219e1
197905lovastatin 40 MG Oral TabletSCD46fe2a49-2ce1-4ddf-bf06-6958b917219e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-549-903326105499090 in 1 BOTTLE, PLASTICHistorical