Lovastatin (Page 11 of 11)


3
National Cholesterol Education Program (NCEP): Highlights of the Report of the Expert Panel on Blood Cholesterol Levels in Children and Adolescents. Pediatrics. 89(3):495–501. 1992.

Concomitant Lipid-Lowering Therapy

Lovastatin is effective alone or when used concomitantly with bile-acid sequestrants (see WARNINGS: Myopathy/Rhabdomyolysis and PRECAUTIONS: Drug Interactions).

Dosage in Patients with Renal Insufficiency

In patients with severe renal insufficiency (creatinine clearance < 30 mL/min), dosage increases above 20 mg/day should be carefully considered and, if deemed necessary, implemented cautiously (see CLINICAL PHARMACOLOGY and WARNINGS: Myopathy/Rhabdomyolysis).

HOW SUPPLIED:

Lovastatin Tablets, USP are available containing 20 mg of lovastatin, USP.

The 20 mg tablets are yellow round, unscored tablets debossed with M over L20 on one side of the tablet and blank on the other side. They are available as follows:

NDC 51079-975-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each).

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]
Protect from light.

Manufactured by:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Distributed by:
Mylan Institutional Inc.
Rockford, IL 61103 U.S.A.

S-12082 R1
6/15

PRINCIPAL DISPLAY PANEL — 20 mg

NDC 51079-975-20

Lovastatin
Tablets, USP
20 mg

100 Tablets (10 x 10)

Each tablet contains:
Lovastatin, USP . . . . 20 mg

Usual Adult Dosage: See
accompanying prescribing
information.

Store at 20° to 25°C (68° to 77°F).
[See USP Controlled Room Temperature.]
Protect from light.

Manufactured by:
Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

Rx only

S-7828 R3

Packaged and Distributed by:

Mylan Institutional Inc.

Rockford, IL 61103 U.S.A.

This unit dose package is not child resistant.

For institutional use only.

Keep this and all drugs out of the reach of children.

This container provides light-resistance.

See window for lot number and expiration date.

Lovastatin 20 mg Tablets Unit Carton Label
(click image for full-size original)
Unit Carton
(click image for full-size original)
LOVASTATIN lovastatin tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51079-975(NDC:0378-6520)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LOVASTATIN (LOVASTATIN) LOVASTATIN 20 mg
Inactive Ingredients
Ingredient Name Strength
BUTYLATED HYDROXYANISOLE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
STARCH, CORN
D&C YELLOW NO. 10
Product Characteristics
Color yellow Score no score
Shape ROUND Size 8mm
Flavor Imprint Code M;L20
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51079-975-20 100 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (51079-975-01)
1 NDC:51079-975-01 1 TABLET in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (51079-975-20)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075451 01/15/2002
Labeler — Mylan Institutional Inc. (039615992)

Revised: 06/2018 Mylan Institutional Inc.

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