FDA.reportPublic FDA data

Lovastatin

Product NDC
0093-0576
11-digit product format
000930576
Labeler code
0093
Product ID
0093-0576_caf8172a-311b-447a-8c8b-e9d70c23c8e8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lovastatin
Dosage form
TABLET
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
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
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
0093-0576-06Lovastatin60 in 1 BOTTLETABLET6021
0093-0576-10Lovastatin1000 in 1 BOTTLETABLET100021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-0576-06EA - Each0093-05760f1ec359-8b9b-4df6-a43c-32b93f24ec5612012-07-24
0093-0576-10EA - Each0093-05769c732b91-ecc3-487e-b7e5-ebb48fbb761212012-07-24
0093-0576-19EA - Each0093-057691148641-6846-4c8d-b5a1-0a0e15d3567b12012-07-24
0093-0576-93EA - Each0093-05761d788279-2f19-44b8-86fa-f6d6571dda7212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LOVASTATINACTIVE INGREDIENT9LHU78OQFDLOVASTATIN TABLET [TEVA PHARMACEUTICALS USA INC]12
LOVASTATINACTIVE MOIETY9LHU78OQFDLOVASTATIN TABLET [TEVA PHARMACEUTICALS USA INC]12
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933LOVASTATIN TABLET [TEVA PHARMACEUTICALS USA INC]12
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2ULOVASTATIN TABLET [TEVA PHARMACEUTICALS USA INC]12
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULOVASTATIN TABLET [TEVA PHARMACEUTICALS USA INC]12
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GLOVASTATIN TABLET [TEVA PHARMACEUTICALS USA INC]12
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDLOVASTATIN TABLET [TEVA PHARMACEUTICALS USA INC]12
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8LOVASTATIN TABLET [TEVA PHARMACEUTICALS USA INC]12
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLOVASTATIN TABLET [TEVA PHARMACEUTICALS USA INC]12
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LOVASTATIN TABLET [TEVA PHARMACEUTICALS USA INC]12
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLOVASTATIN TABLET [TEVA PHARMACEUTICALS USA INC]12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-0576LOVASTATIN TABLET [TEVA PHARMACEUTICALS USA, INC.]21Current NDC, Legacy NDC, 2 package rows20250227_0e15feec-d27e-4861-8152-c5a8b8ccacd4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197903lovastatin 10 MG Oral TabletPSN0e15feec-d27e-4861-8152-c5a8b8ccacd421
197904lovastatin 20 MG Oral TabletPSN0e15feec-d27e-4861-8152-c5a8b8ccacd421
197905lovastatin 40 MG Oral TabletPSN0e15feec-d27e-4861-8152-c5a8b8ccacd421
197903lovastatin 10 MG Oral TabletSCD0e15feec-d27e-4861-8152-c5a8b8ccacd421
197904lovastatin 20 MG Oral TabletSCD0e15feec-d27e-4861-8152-c5a8b8ccacd421
197905lovastatin 40 MG Oral TabletSCD0e15feec-d27e-4861-8152-c5a8b8ccacd421
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
197904lovastatin 20 MG Oral TabletPSN08e8e60d-b90e-419c-a8c7-5765627bd53b3
197904lovastatin 20 MG Oral TabletSCD08e8e60d-b90e-419c-a8c7-5765627bd53b3
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
0093-0576-060009305760660 TABLET in 1 BOTTLE (0093-0576-06) 60 tablet2001-12-170000-00-00NoNoCurrent
0093-0576-10000930576101000 TABLET in 1 BOTTLE (0093-0576-10) 1000 tablet2001-12-170000-00-00NoNoCurrent