Lovastatin

Product NDC
53002-5701
11-digit product format
530025701
Labeler code
53002
Product ID
53002-5701_a5d5d8d8-175a-441f-87b4-88a9a5261913
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lovastatin
Dosage form
TABLET
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA075551
Marketing category
ANDA
Marketing start
2001-12-17
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
No
Listing certified through
2021-12-31
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
53002-5701-0Lovastatin100 in 1 BOTTLETABLET1003
53002-5701-3Lovastatin30 in 1 BOTTLETABLET303
53002-5701-6Lovastatin60 in 1 BOTTLETABLET603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-5701LOVASTATIN TABLET [RPK PHARMACEUTICALS, INC.]3Legacy NDC, 3 package rows20230609_08e8e60d-b90e-419c-a8c7-5765627bd53b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197904lovastatin 20 MG Oral TabletPSN08e8e60d-b90e-419c-a8c7-5765627bd53b3
197904lovastatin 20 MG Oral TabletSCD08e8e60d-b90e-419c-a8c7-5765627bd53b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-5701-053002570100100 TABLET in 1 BOTTLE (53002-5701-0) 100 tablet2020-01-010000-00-00NoNoCurrent
53002-5701-35300257010330 TABLET in 1 BOTTLE (53002-5701-3) 30 tablet2020-01-010000-00-00NoNoCurrent
53002-5701-65300257010660 TABLET in 1 BOTTLE (53002-5701-6) 60 tablet2020-01-010000-00-00NoNoCurrent