FDA.reportPublic FDA data

Lovastatin

Product NDC
68788-8326
11-digit product format
687888326
Labeler code
68788
Product ID
68788-8326_737d8aeb-f192-4b4f-af2a-6a22d4fe6ba1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lovastatin
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA078296
Marketing category
ANDA
Marketing start
2023-01-19
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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-8326-1Lovastatin100 in 1 BOTTLETABLET1003
68788-8326-3Lovastatin30 in 1 BOTTLETABLET303
68788-8326-6Lovastatin60 in 1 BOTTLETABLET603
68788-8326-9Lovastatin90 in 1 BOTTLETABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8326-1EA - Each68788-83269867220d-842a-46a4-9104-fbdfdf9fa22b12023-02-06
68788-8326-3EA - Each68788-8326957cc487-4c2e-47c7-87be-1d9a8d1f25de12023-02-06
68788-8326-6EA - Each68788-832608bee54a-d8e9-4250-83fd-b63c9f94dca212023-02-06
68788-8326-9EA - Each68788-8326d5a2c1cb-f809-46b3-b831-23391e19be7112023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8326LOVASTATIN TABLET [PREFERRED PHARMACEUTICALS, INC.]2Current NDC, 4 package rows20240704_22c9f2d8-7bcd-4415-bbc8-505720033966.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197904lovastatin 20 MG Oral TabletPSN22c9f2d8-7bcd-4415-bbc8-5057200339663
197904lovastatin 20 MG Oral TabletSCD22c9f2d8-7bcd-4415-bbc8-5057200339663

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8326-168788832601100 TABLET in 1 BOTTLE (68788-8326-1) 100 tablet2023-01-19NoNoCurrent
68788-8326-36878883260330 TABLET in 1 BOTTLE (68788-8326-3) 30 tablet2023-01-19NoNoCurrent
68788-8326-66878883260660 TABLET in 1 BOTTLE (68788-8326-6) 60 tablet2023-01-19NoNoCurrent
68788-8326-96878883260990 TABLET in 1 BOTTLE (68788-8326-9) 90 tablet2023-01-19NoNoCurrent