Lovastatin

Product NDC
53217-304
11-digit product format
532170304
Labeler code
53217
Product ID
53217-304_c7fd107c-3617-431e-be92-01c5e88a5662
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lovastatin
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA078296
Marketing category
ANDA
Marketing start
2007-11-01
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
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53217-304-02Lovastatin120 in 1 BOTTLETABLET1201
53217-304-30Lovastatin30 in 1 BOTTLETABLET301
53217-304-90Lovastatin90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53217-304-02EA - Each53217-30406a55304-17dc-463e-8087-4097b6c0676b12017-07-07
53217-304-30EA - Each53217-304708fddbc-a72f-45e8-babe-9de29ef502fd12017-07-07
53217-304-90EA - Each53217-30473bc4ccf-3c98-47ae-ad3e-14add60b570412017-07-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53217-304LOVASTATIN TABLET [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 3 package rows20170525_f208f4a4-cb3f-40bd-9873-bba0c8ae8bd4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197903lovastatin 10 MG Oral TabletPSNf208f4a4-cb3f-40bd-9873-bba0c8ae8bd41
197903lovastatin 10 MG Oral TabletSCDf208f4a4-cb3f-40bd-9873-bba0c8ae8bd41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53217-304-0253217030402120 in 1 BOTTLEHistorical
53217-304-305321703043030 in 1 BOTTLEHistorical
53217-304-905321703049090 in 1 BOTTLEHistorical