Lovastatin

Product NDC
10544-241
11-digit product format
105440241
Labeler code
10544
Product ID
10544-241_0f88a46a-8488-3f5b-e054-00144ff88e88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lovastatin
Dosage form
TABLET
Route
ORAL
Labeler
Blenheim Pharmacal, Inc.
Application
ANDA075991
Marketing category
ANDA
Marketing start
2013-10-09
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
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
10544-241-302020-01-31C16284748780-19d75b9cf-d616-f424-e053-dadaa90a57ceLovastatin Tablet USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10544-241-30Lovastatin30 in 1 BOTTLETABLET301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10544-241-30EA - Each10544-241f670f82c-60a9-497a-88fb-25dde917d75412015-04-03

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10544-241LOVASTATIN TABLET [BLENHEIM PHARMACAL, INC.]1Legacy NDC, 1 package rows20150223_0f88a46a-8487-3f5b-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197903lovastatin 10 MG Oral TabletPSN0f88a46a-8487-3f5b-e054-00144ff88e881
197904lovastatin 20 MG Oral TabletPSN0f88a46a-8487-3f5b-e054-00144ff88e881
197905lovastatin 40 MG Oral TabletPSN0f88a46a-8487-3f5b-e054-00144ff88e881
197903lovastatin 10 MG Oral TabletSCD0f88a46a-8487-3f5b-e054-00144ff88e881
197904lovastatin 20 MG Oral TabletSCD0f88a46a-8487-3f5b-e054-00144ff88e881
197905lovastatin 40 MG Oral TabletSCD0f88a46a-8487-3f5b-e054-00144ff88e881

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10544-241-301054402413030 in 1 BOTTLEHistorical