FDA.reportPublic FDA data

Lovastatin

Product NDC
71205-994
11-digit product format
712050994
Labeler code
71205
Product ID
71205-994_e637904d-8af6-47fe-b10e-db813d5531bc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lovastatin
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA075991
Marketing category
ANDA
Marketing start
2002-11-25
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
71205-994-00Lovastatin100 in 1 BOTTLETABLET1004
71205-994-11Lovastatin1000 in 1 BOTTLETABLET10004
71205-994-30Lovastatin30 in 1 BOTTLETABLET304
71205-994-55Lovastatin500 in 1 BOTTLETABLET5004
71205-994-60Lovastatin60 in 1 BOTTLETABLET604
71205-994-90Lovastatin90 in 1 BOTTLETABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-994-00EA - Each71205-994b9684157-3496-4528-829a-6362cf77ea2912021-06-02
71205-994-11EA - Each71205-994d05fcd66-f9ce-49d3-80e3-2d9e92304ef612021-06-02
71205-994-30EA - Each71205-994cb576dba-8214-486c-890a-8f35a4fd46ad12021-06-02
71205-994-55EA - Each71205-9945e88cde2-b782-4a43-a7a6-25d441ef848d12021-06-02
71205-994-60EA - Each71205-994233ea390-de89-45dd-b5b6-368de8cb5a0212021-06-02
71205-994-90EA - Each71205-994ee7c345a-5cef-41bf-8e7b-8da8ce65a37712021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-994LOVASTATIN TABLET [PROFICIENT RX LP]4Current NDC, Legacy NDC, 6 package rows20220716_25efd38a-1495-4824-9137-a3429bc471bd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197903lovastatin 10 MG Oral TabletPSN25efd38a-1495-4824-9137-a3429bc471bd4
197904lovastatin 20 MG Oral TabletPSN25efd38a-1495-4824-9137-a3429bc471bd4
197905lovastatin 40 MG Oral TabletPSN25efd38a-1495-4824-9137-a3429bc471bd4
197903lovastatin 10 MG Oral TabletSCD25efd38a-1495-4824-9137-a3429bc471bd4
197904lovastatin 20 MG Oral TabletSCD25efd38a-1495-4824-9137-a3429bc471bd4
197905lovastatin 40 MG Oral TabletSCD25efd38a-1495-4824-9137-a3429bc471bd4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-994-0071205099400100 TABLET in 1 BOTTLE (71205-994-00) 100 tablet2020-04-010000-00-00NoNoCurrent
71205-994-11712050994111000 TABLET in 1 BOTTLE (71205-994-11) 1000 tablet2020-04-010000-00-00NoNoCurrent
71205-994-307120509943030 TABLET in 1 BOTTLE (71205-994-30) 30 tablet2020-04-010000-00-00NoNoCurrent
71205-994-5571205099455500 TABLET in 1 BOTTLE (71205-994-55) 500 tablet2020-04-010000-00-00NoNoCurrent
71205-994-607120509946060 TABLET in 1 BOTTLE (71205-994-60) 60 tablet2020-04-010000-00-00NoNoCurrent
71205-994-907120509949090 TABLET in 1 BOTTLE (71205-994-90) 90 tablet2020-04-010000-00-00NoNoCurrent