FDA.reportPublic FDA data

Lovastatin

Product NDC
70518-3064
11-digit product format
705183064
Labeler code
70518
Product ID
70518-3064_4e90ea05-c099-5658-e063-6394a90a1c44
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lovastatin
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA075551
Marketing category
ANDA
Marketing start
2021-04-02
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-3064-02023-03-15C16284748780-1f386c64a-2b58-0266-e053-dadaa90a7c1aLovastatin Tablets, USP Rx only
70518-3064-12023-03-15C16284748780-1f386c64a-2b58-0266-e053-dadaa90a7c1aLovastatin Tablets, USP Rx only
70518-3064-02023-01-30C16284748780-1f386c64a-2b58-0266-e053-dadaa90a7c1aLovastatin Tablets, USP Rx only
70518-3064-12023-01-30C16284748780-1f386c64a-2b58-0266-e053-dadaa90a7c1aLovastatin Tablets, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-3064-0Lovastatin90 in 1 BOTTLE, PLASTICTABLET906
70518-3064-1Lovastatin30 in 1 BLISTER PACKTABLET306

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3064LOVASTATIN TABLET [REMEDYREPACK INC.]4Current NDC, Legacy NDC, 2 package rows20240312_a902a95f-072a-4487-99a9-109a93f8b23c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197905lovastatin 40 MG Oral TabletPSNa902a95f-072a-4487-99a9-109a93f8b23c6
197905lovastatin 40 MG Oral TabletSCDa902a95f-072a-4487-99a9-109a93f8b23c6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3064-07051830640090 TABLET in 1 BOTTLE, PLASTIC (70518-3064-0) 90 tablet2021-04-020000-00-00NoNoCurrent
70518-3064-17051830640130 TABLET in 1 BLISTER PACK (70518-3064-1) 30 tablet2021-05-120000-00-00NoNoCurrent