Lovastatin

Product NDC
51655-469
11-digit product format
516550469
Labeler code
51655
Product ID
51655-469_49ee2c9e-f0db-74af-e063-6394a90a53b9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lovastatin
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA078296
Marketing category
ANDA
Marketing start
2022-11-30
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Lovastatin
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LOVASTATIN40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9LHU78OQFD
Rxcui197905

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
51655-469-26Lovastatin90 in 1 BOTTLE, PLASTICTABLET903
51655-469-52Lovastatin30 in 1 BOTTLE, PLASTICTABLET303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-469LOVASTATIN TABLET [NORTHWIND PHARMACEUTICALS, LLC]2Current NDC, 2 package rows20230701_f308fe1c-23a9-6409-e053-2995a90abfd9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197905lovastatin 40 MG Oral TabletPSNf308fe1c-23a9-6409-e053-2995a90abfd93
197905lovastatin 40 MG Oral TabletSCDf308fe1c-23a9-6409-e053-2995a90abfd93

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51655-469-265165504692690 TABLET in 1 BOTTLE, PLASTIC (51655-469-26) 90 tablet2023-03-22NoNoHistorical
51655-469-525165504695230 TABLET in 1 BOTTLE, PLASTIC (51655-469-52) 30 tablet2022-11-30NoNoHistorical