FDA.reportPublic FDA data

Lovastatin

Product NDC
72162-1739
11-digit product format
721621739
Labeler code
72162
Product ID
72162-1739_c3daa4ef-b136-479f-b7f7-48ef98c763d5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lovastatin
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
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

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
72162-1739-0Lovastatin1000 in 1 BOTTLETABLET1000104
72162-1739-2Lovastatin100 in 1 BOTTLETABLET100104
72162-1739-4Lovastatin300 in 1 BOTTLETABLET300104
72162-1739-5Lovastatin500 in 1 BOTTLETABLET500104
72162-1739-6Lovastatin60 in 1 BOTTLETABLET60104
72162-1739-7Lovastatin120 in 1 BOTTLETABLET120104
72162-1739-9Lovastatin90 in 1 BOTTLETABLET90104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1739-0EA - Each72162-173917466cd6-a469-40a8-a4e9-aeb10e754c6d12024-01-04
72162-1739-2EA - Each72162-1739fe38879a-6cdd-4f36-9199-0c94f1fe64a712023-12-05
72162-1739-4EA - Each72162-1739c74452e4-1acc-4bd0-ad82-538f902c10b212024-08-12
72162-1739-5EA - Each72162-173962e975f2-b710-4282-9404-15a7745e02bf12024-01-04
72162-1739-6EA - Each72162-1739c8012dff-2308-40b0-bbf3-a5367c41ee4f12024-08-12
72162-1739-7EA - Each72162-1739b5033e85-ab28-411c-83ed-0ee83c756d6f12023-12-05
72162-1739-9EA - Each72162-1739c8abddfb-bf98-4e83-b15c-363d218e3c4112024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1739LOVASTATIN TABLET [BRYANT RANCH PREPACK]104Current NDC, 7 package rows20250403_220a9b3c-c583-49e3-8bf0-d0c97dc9b829.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197903lovastatin 10 MG Oral TabletPSN220a9b3c-c583-49e3-8bf0-d0c97dc9b829104
197903lovastatin 10 MG Oral TabletSCD220a9b3c-c583-49e3-8bf0-d0c97dc9b829104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-1739-0721621739001000 TABLET in 1 BOTTLE (72162-1739-0) 1000 tablet2024-08-12NoNoHistorical
72162-1739-272162173902100 TABLET in 1 BOTTLE (72162-1739-2) 100 tablet2024-08-12NoNoHistorical
72162-1739-472162173904300 TABLET in 1 BOTTLE (72162-1739-4) 300 tablet2024-08-12NoNoHistorical
72162-1739-572162173905500 TABLET in 1 BOTTLE (72162-1739-5) 500 tablet2024-08-12NoNoHistorical
72162-1739-67216217390660 TABLET in 1 BOTTLE (72162-1739-6) 60 tablet2024-08-12NoNoHistorical
72162-1739-772162173907120 TABLET in 1 BOTTLE (72162-1739-7) 120 tablet2024-08-12NoNoHistorical
72162-1739-97216217390990 TABLET in 1 BOTTLE (72162-1739-9) 90 tablet2024-08-12NoNoHistorical