FDA.reportPublic FDA data

Lovastatin

Product NDC
63629-1464
11-digit product format
636291464
Labeler code
63629
Product ID
63629-1464_3d49c74d-cb52-4c1e-9982-862f00e848f6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lovastatin
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA075991
Marketing category
ANDA
Marketing start
2002-11-25
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Lovastatin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LOVASTATIN20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9LHU78OQFD
Rxcui197904

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-1464-1Lovastatin30 in 1 BOTTLETABLET301006
63629-1464-2Lovastatin100 in 1 BOTTLETABLET1001006
63629-1464-3Lovastatin60 in 1 BOTTLETABLET601006
63629-1464-4Lovastatin90 in 1 BOTTLETABLET901006
63629-1464-5Lovastatin20 in 1 BOTTLETABLET201006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-1464-1EA - Each63629-146491363075-f6d0-447d-9c73-78d344aa2e1512013-02-13
63629-1464-2EA - Each63629-1464c3b77c56-7169-4e83-b007-25c677b753d312013-02-13
63629-1464-3EA - Each63629-1464d0a342c2-1971-421c-87ce-729a02309b6112013-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-1464LOVASTATIN TABLET [BRYANT RANCH PREPACK]1006Current NDC, Legacy NDC, 5 package rows20240816_ad905651-6e3a-4140-aa37-d91e5f37c0f0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197904lovastatin 20 MG Oral TabletPSNad905651-6e3a-4140-aa37-d91e5f37c0f01006
197904lovastatin 20 MG Oral TabletSCDad905651-6e3a-4140-aa37-d91e5f37c0f01006

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-1464-16362914640130 TABLET in 1 BOTTLE (63629-1464-1) 30 tablet2005-01-260000-00-00NoNoCurrent
63629-1464-263629146402100 TABLET in 1 BOTTLE (63629-1464-2) 100 tablet2009-09-300000-00-00NoNoCurrent
63629-1464-36362914640360 TABLET in 1 BOTTLE (63629-1464-3) 60 tablet2009-01-190000-00-00NoNoCurrent
63629-1464-46362914640490 TABLET in 1 BOTTLE (63629-1464-4) 90 tablet2012-06-120000-00-00NoNoCurrent
63629-1464-56362914640520 TABLET in 1 BOTTLE (63629-1464-5) 20 tablet2018-12-260000-00-00NoNoCurrent