FDA.reportPublic FDA data

Lovastatin

Product NDC
51655-558
11-digit product format
516550558
Labeler code
51655
Product ID
51655-558_4a2ad2a0-8293-8eed-e063-6394a90a98f2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lovastatin
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA078296
Marketing category
ANDA
Marketing start
2021-01-25
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
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
LOVASTATIN20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9LHU78OQFD
Rxcui197904

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51655-558-262026-01-29C16284748780-1f386c649-a643-0266-e053-dadaa90a7c1aLOVASTATIN TABLETS USP 10 mg, 20 mg and 40 mg Rx only
51655-558-522026-01-29C16284748780-1f386c649-a643-0266-e053-dadaa90a7c1aLOVASTATIN TABLETS USP 10 mg, 20 mg and 40 mg Rx only
51655-558-262023-03-17C16284748780-1f386c649-a643-0266-e053-dadaa90a7c1aLOVASTATIN TABLETS USP 10 mg, 20 mg and 40 mg Rx only
51655-558-262023-01-30C16284748780-1f386c649-a643-0266-e053-dadaa90a7c1aLOVASTATIN TABLETS USP 10 mg, 20 mg and 40 mg Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51655-558-26Lovastatin90 in 1 BOTTLE, PLASTICTABLET903
51655-558-52Lovastatin30 in 1 BOTTLE, PLASTICTABLET303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-558LOVASTATIN TABLET [NORTHWIND PHARMACEUTICALS, LLC]2Current NDC, Legacy NDC, 2 package rows20230318_ca59cbd4-a4c1-aebe-e053-2a95a90ae968.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197904lovastatin 20 MG Oral TabletPSNca59cbd4-a4c1-aebe-e053-2a95a90ae9683
197904lovastatin 20 MG Oral TabletSCDca59cbd4-a4c1-aebe-e053-2a95a90ae9683

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51655-558-265165505582690 TABLET in 1 BOTTLE, PLASTIC (51655-558-26) 90 tablet2021-01-250000-00-00NoNoCurrent
51655-558-525165505585230 TABLET in 1 BOTTLE, PLASTIC (51655-558-52) 30 tablet2023-02-20NoNoCurrent