FDA.reportPublic FDA data

Lovastatin

Product NDC
51407-253
11-digit product format
514070253
Labeler code
51407
Product ID
51407-253_46049ec7-69c6-fab7-e063-6294a90acd9b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lovastatin
Dosage form
TABLET
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA075551
Marketing category
ANDA
Marketing start
2001-12-17
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
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
LOVASTATIN40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9LHU78OQFD
Rxcui197903, 197904, 197905

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
51407-253-10Lovastatin1000 in 1 BOTTLETABLET10006
51407-253-60Lovastatin60 in 1 BOTTLETABLET606
51407-253-90Lovastatin90 in 1 BOTTLETABLET906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51407-253-10EA - Each51407-2536d027e66-5049-4b65-9334-c46a99af41ef12019-12-10
51407-253-60EA - Each51407-2530ec7a4a7-c6d0-42ef-9ce1-8198a7fa775a12019-12-10
51407-253-90EA - Each51407-253706f1286-0fb1-48df-adb7-2a27a2d2da3512019-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51407-253LOVASTATIN TABLET [GOLDEN STATE MEDICAL SUPPLY]5Current NDC, Legacy NDC, 3 package rows20231230_91332c54-1a27-4e6b-e053-2a95a90a42cd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197903lovastatin 10 MG Oral TabletPSN91332c54-1a27-4e6b-e053-2a95a90a42cd6
197904lovastatin 20 MG Oral TabletPSN91332c54-1a27-4e6b-e053-2a95a90a42cd6
197905lovastatin 40 MG Oral TabletPSN91332c54-1a27-4e6b-e053-2a95a90a42cd6
197903lovastatin 10 MG Oral TabletSCD91332c54-1a27-4e6b-e053-2a95a90a42cd6
197904lovastatin 20 MG Oral TabletSCD91332c54-1a27-4e6b-e053-2a95a90a42cd6
197905lovastatin 40 MG Oral TabletSCD91332c54-1a27-4e6b-e053-2a95a90a42cd6
197905lovastatin 40 MG Oral TabletPSN65e0bfa6-fd11-4fda-bec5-359201da60a01
197905lovastatin 40 MG Oral TabletPSN7e96b174-3887-4908-9b9f-5ef93540f96a1
197905lovastatin 40 MG Oral TabletSCD65e0bfa6-fd11-4fda-bec5-359201da60a01
197905lovastatin 40 MG Oral TabletSCD7e96b174-3887-4908-9b9f-5ef93540f96a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51407-253-10514070253101000 TABLET in 1 BOTTLE (51407-253-10) 1000 tablet2019-08-200000-00-00NoNoCurrent
51407-253-605140702536060 TABLET in 1 BOTTLE (51407-253-60) 60 tablet2019-08-200000-00-00NoNoCurrent
51407-253-905140702539090 TABLET in 1 BOTTLE (51407-253-90) 90 tablet2019-08-200000-00-00NoNoCurrent