FDA.reportPublic FDA data

Lovastatin

Product NDC
43063-692
11-digit product format
430630692
Labeler code
43063
Product ID
43063-692_2fb37b45-9a7a-b6cd-e063-6294a90abe42
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lovastatin
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA075991
Marketing category
ANDA
Marketing start
2002-11-25
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
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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43063-692-30Lovastatin30 in 1 BOTTLE, PLASTICTABLET3023
43063-692-90Lovastatin90 in 1 BOTTLE, PLASTICTABLET9023
43063-692-93Lovastatin180 in 1 BOTTLE, PLASTICTABLET18023
43063-692-95Lovastatin1000 in 1 BOTTLE, PLASTICTABLET100023

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-692-30EA - Each43063-692d5521ece-1652-478d-af34-765d2c3846ee12023-09-05
43063-692-90EA - Each43063-6923e914b1d-0172-4756-8046-3b3adddcae0312016-09-02
43063-692-93EA - Each43063-6920d908a28-2107-4713-b650-dc2996ee52fc12016-09-02
43063-692-95EA - Each43063-6927520871f-d436-47c4-80f9-0a21513ab96d12022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-692LOVASTATIN TABLET [PD-RX PHARMACEUTICALS, INC.]23Current NDC, Legacy NDC, 4 package rows20250309_70e2bf86-4a78-4dfb-b6b1-8eb95f63684d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197904lovastatin 20 MG Oral TabletPSN70e2bf86-4a78-4dfb-b6b1-8eb95f63684d23
197904lovastatin 20 MG Oral TabletSCD70e2bf86-4a78-4dfb-b6b1-8eb95f63684d23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43063-692-304306306923030 TABLET in 1 BOTTLE, PLASTIC (43063-692-30) 30 tablet2023-07-31NoNoCurrent
43063-692-904306306929090 TABLET in 1 BOTTLE, PLASTIC (43063-692-90) 90 tablet2016-07-260000-00-00NoNoCurrent
43063-692-9343063069293180 TABLET in 1 BOTTLE, PLASTIC (43063-692-93) 180 tablet2016-07-260000-00-00NoNoCurrent
43063-692-95430630692951000 TABLET in 1 BOTTLE, PLASTIC (43063-692-95) 1000 tablet2022-10-030000-00-00NoNoCurrent