Lovastatin

Product NDC
68788-8287
11-digit product format
687888287
Labeler code
68788
Product ID
68788-8287_89cfb920-9cab-43b2-a6d9-33e6e62fbeb5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lovastatin
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA078296
Marketing category
ANDA
Marketing start
2022-11-17
Substance
LOVASTATIN
Active strength
10 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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
9LHU78OQFDLOVASTATIN75330-75-5LOVASTATIN

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8287-168788828701100 TABLET in 1 BOTTLE (68788-8287-1) 100 tablet2022-11-17NoNoHistorical
68788-8287-36878882870330 TABLET in 1 BOTTLE (68788-8287-3) 30 tablet2022-11-17NoNoHistorical
68788-8287-66878882870660 TABLET in 1 BOTTLE (68788-8287-6) 60 tablet2022-11-17NoNoHistorical
68788-8287-96878882870990 TABLET in 1 BOTTLE (68788-8287-9) 90 tablet2022-11-17NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
LOVASTATIN TABLETS USP 10 mg, 20 mg and 40 mg Rx onlyPreferred Pharmaceuticals, Inc.2025-08-04HUMAN PRESCRIPTION DRUG LABEL4