LOVASTATIN

Product NDC
54458-844
11-digit product format
544580844
Labeler code
54458
Product ID
54458-844_28322af3-4689-4df8-990b-d105d8ba284e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LOVASTATIN
Dosage form
TABLET
Route
ORAL
Labeler
International Laboratories, LLC
Application
ANDA075551
Marketing category
ANDA
Marketing start
2017-06-07
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
2020-12-31
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
54458-844-162023-01-30C16284748780-1f386c649-dbca-0266-e053-dadaa90a7c1aLOVASTATIN TABLETS USP Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54458-844-16LOVASTATIN30 in 1 BOTTLETABLET304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54458-844-16EA - Each54458-84487c4e258-6cde-484e-a0f1-a2f0ba59ca6f12017-07-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54458-844LOVASTATIN TABLET [INTERNATIONAL LABORATORIES, LLC]4Legacy NDC, 1 package rows20191219_b500eba1-422a-4590-921c-569e2bca90fb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197903lovastatin 10 MG Oral TabletPSNb500eba1-422a-4590-921c-569e2bca90fb4
197904lovastatin 20 MG Oral TabletPSNb500eba1-422a-4590-921c-569e2bca90fb4
197905lovastatin 40 MG Oral TabletPSNb500eba1-422a-4590-921c-569e2bca90fb4
197903lovastatin 10 MG Oral TabletSCDb500eba1-422a-4590-921c-569e2bca90fb4
197904lovastatin 20 MG Oral TabletSCDb500eba1-422a-4590-921c-569e2bca90fb4
197905lovastatin 40 MG Oral TabletSCDb500eba1-422a-4590-921c-569e2bca90fb4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54458-844-165445808441630 TABLET in 1 BOTTLE (54458-844-16) 30 tablet2017-06-070000-00-00NoNoCurrent