FDA Product

LOVASTATIN

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Product Name

LOVASTATIN

FDA Product Code

54868-4585

Regulatory Information

NDC Product Code

54868-4585

Application Number

ANDA078296

Marketing Category

C73584

Effective Date

March 28, 2011

Territorial Authority

USA

FDA Title

LOVASTATIN TABLETS USP10 mg, 20 mg and 40 mgRx only

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

1

Company Information

ManufacturerPhysicians Total Care, Inc.

DUNS Number

194123980

Active Ingredients

Quantity: 20 mg in 1 1

Code: 9LHU78OQFD

Class Code: ACTIB

ANHYDROUS LACTOSE

Code: 3SY5LH9PMK

Class Code: IACT

D&C YELLOW NO. 10

Code: 35SW5USQ3G

Class Code: IACT

FD&C BLUE NO. 2

Code: L06K8R7DQK

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

BUTYLATED HYDROXYANISOLE

Code: REK4960K2U

Class Code: IACT

Active Moieties

LOVASTATIN

Code: 9LHU78OQFD

© Copyright 2025. All Rights Reserved by MedPath

Home Terms & Conditions Privacy Policy