FDA.reportPublic FDA data

Lovastatin

Product NDC
71205-440
11-digit product format
712050440
Labeler code
71205
Product ID
71205-440_027bd594-6a0a-4e6d-bd3c-4f33fdb4166a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lovastatin
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA075551
Marketing category
ANDA
Marketing start
2001-12-17
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
71205-440-30Lovastatin30 in 1 BOTTLETABLET301
71205-440-60Lovastatin60 in 1 BOTTLETABLET601
71205-440-90Lovastatin90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-440-30EA - Each71205-440c024a553-60f6-434a-bff6-2420f29bebff12020-05-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-440LOVASTATIN TABLET [PROFICIENT RX LP]1Current NDC, Legacy NDC, 3 package rows20200403_027bd594-6a0a-4e6d-bd3c-4f33fdb4166a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197904lovastatin 20 MG Oral TabletPSN027bd594-6a0a-4e6d-bd3c-4f33fdb4166a1
197904lovastatin 20 MG Oral TabletSCD027bd594-6a0a-4e6d-bd3c-4f33fdb4166a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-440-307120504403030 TABLET in 1 BOTTLE (71205-440-30) 30 tablet2020-04-010000-00-00NoNoCurrent
71205-440-607120504406060 TABLET in 1 BOTTLE (71205-440-60) 60 tablet2020-04-010000-00-00NoNoCurrent
71205-440-907120504409090 TABLET in 1 BOTTLE (71205-440-90) 90 tablet2020-04-010000-00-00NoNoCurrent