Lovastatin (Page 11 of 11)

HOW SUPPLIED

Lovastatin Tablets USP, 10 mg are available as light peach, unscored, round, flat beveled tablets debossed “926” on one side and “TEVA” on the other side. Packaged in bottles of 60 (NDC 0093-0926-06) and 1000 (NDC 0093-0926-10).

Lovastatin Tablets USP, 20 mg are available as light blue, unscored, round, flat beveled tablets, debossed “576” on one side and “TEVA” on the other side. Packaged in bottles of 60 (NDC 0093-0576-06) and 1000 (NDC 0093-0576-10).

Lovastatin Tablets USP, 40 mg are available as light green, unscored, round, flat beveled tablets, debossed “928” on one side and “TEVA” on the other side. Packaged in bottles of 60 (NDC 0093-0928-06) and 1000 (NDC 0093-0928-10).

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Lovastatin Tablets, USP must be protected from light.

Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Manufactured In Croatia By:

Pliva Hrvatska d.o.o.

Zagreb, Croatia

Manufactured For:

Teva Pharmaceuticals USA, Inc.

Parsippany, NJ 07054

Rev. U 7/2020

Package/Label Display Panel

NDC 0093-0926- 06

Lovastatin
Tablets, USP
10 mg

Rx only

60 TABLETS

TEVA

image
(click image for full-size original)

Package/Label Display Panel

NDC 0093-0576- 06

Lovastatin
Tablets, USP
20 mg

Rx only

60 TABLETS

TEVA

image
(click image for full-size original)

Package/Label Display Panel

NDC 0093-0928- 06

Lovastatin
Tablets, USP
40 mg

Rx only

60 TABLETS

TEVA

image
(click image for full-size original)
LOVASTATIN
lovastatin tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-0926
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LOVASTATIN (LOVASTATIN) LOVASTATIN 10 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
BUTYLATED HYDROXYANISOLE
FD&C YELLOW NO. 6
Product Characteristics
Color ORANGE (Light Peach) Score no score
Shape ROUND Size 9mm
Flavor Imprint Code 926;TEVA
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0093-0926-06 60 TABLET in 1 BOTTLE None
2 NDC:0093-0926-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075551 12/17/2001
LOVASTATIN
lovastatin tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-0576
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
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
BUTYLATED HYDROXYANISOLE
FD&C BLUE NO. 1
Product Characteristics
Color BLUE (Light Blue) Score no score
Shape ROUND Size 9mm
Flavor Imprint Code 576;TEVA
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0093-0576-06 60 TABLET in 1 BOTTLE None
2 NDC:0093-0576-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075551 12/17/2001
LOVASTATIN
lovastatin tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-0928
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LOVASTATIN (LOVASTATIN) LOVASTATIN 40 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
BUTYLATED HYDROXYANISOLE
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C YELLOW NO. 6
Product Characteristics
Color GREEN (Light Green) Score no score
Shape ROUND Size 9mm
Flavor Imprint Code 928;TEVA
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0093-0928-06 60 TABLET in 1 BOTTLE None
2 NDC:0093-0928-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075551 12/17/2001
Labeler — Teva Pharmaceuticals USA, Inc. (001627975)

Revised: 07/2020 Teva Pharmaceuticals USA, Inc.

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