FDA.reportPublic FDA data

Lovastatin

Product NDC
71205-992
11-digit product format
712050992
Labeler code
71205
Product ID
71205-992_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
10 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
LOVASTATIN10 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
71205-992-00Lovastatin100 in 1 BOTTLETABLET1004
71205-992-11Lovastatin1000 in 1 BOTTLETABLET10004
71205-992-30Lovastatin30 in 1 BOTTLETABLET304
71205-992-55Lovastatin500 in 1 BOTTLETABLET5004
71205-992-60Lovastatin60 in 1 BOTTLETABLET604
71205-992-90Lovastatin90 in 1 BOTTLETABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-992-00EA - Each71205-992a8787a03-edf2-43bb-888c-81561b70090b12021-06-02
71205-992-11EA - Each71205-992807cb73c-916d-409f-a565-effaa6fe232012021-06-02
71205-992-30EA - Each71205-9924396e053-8c2f-4a83-9b40-72df22b7625c12021-06-02
71205-992-55EA - Each71205-99252942f5e-c04f-4923-8d15-d1a1e4278f4c12021-06-02
71205-992-60EA - Each71205-9925331c58a-2b61-48f2-9e4a-ad87187ac65612021-06-02
71205-992-90EA - Each71205-992f6aaddc4-2a0e-4b07-8132-fe5f78a3d08d12021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-992LOVASTATIN 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
71205-992-0071205099200100 TABLET in 1 BOTTLE (71205-992-00) 100 tablet2020-04-010000-00-00NoNoCurrent
71205-992-11712050992111000 TABLET in 1 BOTTLE (71205-992-11) 1000 tablet2020-04-010000-00-00NoNoCurrent
71205-992-307120509923030 TABLET in 1 BOTTLE (71205-992-30) 30 tablet2020-04-010000-00-00NoNoCurrent
71205-992-5571205099255500 TABLET in 1 BOTTLE (71205-992-55) 500 tablet2020-04-010000-00-00NoNoCurrent
71205-992-607120509926060 TABLET in 1 BOTTLE (71205-992-60) 60 tablet2020-04-010000-00-00NoNoCurrent
71205-992-907120509929090 TABLET in 1 BOTTLE (71205-992-90) 90 tablet2020-04-010000-00-00NoNoCurrent