FDA.reportPublic FDA data

Lovastatin

Product NDC
71205-199
11-digit product format
712050199
Labeler code
71205
Product ID
71205-199_7e11954b-93e7-4984-9560-c52eafc2e2e0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lovastatin
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA078296
Marketing category
ANDA
Marketing start
2007-11-01
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
Rxcui197905

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
71205-199-30Lovastatin30 in 1 BOTTLETABLET304
71205-199-60Lovastatin60 in 1 BOTTLETABLET604
71205-199-90Lovastatin90 in 1 BOTTLETABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-199-30EA - Each71205-199f24d3c19-c147-48d9-b90e-db3ca22d83f612019-05-02
71205-199-90EA - Each71205-199c97c1172-62ff-406d-909b-4e5bcba6538412019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-199LOVASTATIN TABLET [PROFICIENT RX LP]4Current NDC, Legacy NDC, 3 package rows20220930_eb3b4051-3901-461d-a982-7ecd115ba669.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197905lovastatin 40 MG Oral TabletPSNeb3b4051-3901-461d-a982-7ecd115ba6694
197905lovastatin 40 MG Oral TabletSCDeb3b4051-3901-461d-a982-7ecd115ba6694

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-199-307120501993030 TABLET in 1 BOTTLE (71205-199-30) 30 tablet2019-01-010000-00-00NoNoCurrent
71205-199-607120501996060 TABLET in 1 BOTTLE (71205-199-60) 60 tablet2019-01-010000-00-00NoNoCurrent
71205-199-907120501999090 TABLET in 1 BOTTLE (71205-199-90) 90 tablet2019-01-010000-00-00NoNoCurrent