NDC Code(s) : 0378-6510-91, 0378-6520-91, 0378-6540-91
Packager : Mylan Pharmaceuticals Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

LovastatinLovastatin TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-6510
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LOVASTATIN(UNII: 9LHU78OQFD)
(LOVASTATIN - UNII:9LHU78OQFD) 		LOVASTATIN10 mg
Inactive Ingredients
Ingredient Name Strength
BUTYLATED HYDROXYANISOLE(UNII: REK4960K2U)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
STARCH, CORN(UNII: O8232NY3SJ)
Product Characteristics
Color WHITE (white to off-white) Score no score
Shape ROUND Size 8 mm
Flavor Imprint Code M;L19
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0378-6510-9160 in 1 BOTTLE Type 0: Not a Combination Product17/12/2001
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075451 12/17/2001 11/30/2018
LovastatinLovastatin TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-6520
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LOVASTATIN(UNII: 9LHU78OQFD)
(LOVASTATIN - UNII:9LHU78OQFD) 		LOVASTATIN20 mg
Inactive Ingredients
Ingredient Name Strength
BUTYLATED HYDROXYANISOLE(UNII: REK4960K2U)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
STARCH, CORN(UNII: O8232NY3SJ)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
Product Characteristics
Color YELLOW Score no score
Shape ROUND Size 8 mm
Flavor Imprint Code M;L20
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0378-6520-9160 in 1 BOTTLE Type 0: Not a Combination Product17/12/2001
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075451 12/17/2001 11/30/2018
LovastatinLovastatin TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-6540
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LOVASTATIN(UNII: 9LHU78OQFD)
(LOVASTATIN - UNII:9LHU78OQFD) 		LOVASTATIN40 mg
Inactive Ingredients
Ingredient Name Strength
BUTYLATED HYDROXYANISOLE(UNII: REK4960K2U)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
STARCH, CORN(UNII: O8232NY3SJ)
D&C RED NO. 30(UNII: 2S42T2808B)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
Product Characteristics
Color PINK Score no score
Shape ROUND Size 8 mm
Flavor Imprint Code M;L21
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0378-6540-9160 in 1 BOTTLE Type 0: Not a Combination Product17/12/2001
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075451 12/17/2001 11/30/2018

PRINCIPAL DISPLAY PANEL

NDC 0378-6510-91

Lovastatin
Tablets, USP
10 mg

Rx only 60 Tablets

Each tablet contains:
Lovastatin, USP 10 mg

Dispense in a tight, light-resistant
container as defined in the USP
using a child-resistant closure.

Keep container tightly closed.

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

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

Protect from light.

Usual Adult Dosage: See
accompanying prescribing
information.

Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Mylan.com

RM6510D5

Lovastatin Tablets 10 mg Bottle Labels

PRINCIPAL DISPLAY PANEL

NDC 0378-6520-91

Lovastatin
Tablets, USP
20 mg

Rx only 60 Tablets

Each tablet contains:
Lovastatin, USP 20 mg

Dispense in a tight, light-resistant
container as defined in the USP
using a child-resistant closure.

Keep container tightly closed.

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

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

Protect from light.

Usual Adult Dosage: See
accompanying prescribing
information.

Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Mylan.com

RM6520D5

Lovastatin Tablets 20 mg Bottle Labels

PRINCIPAL DISPLAY PANEL

NDC 0378-6540-91

Lovastatin
Tablets, USP
40 mg

Rx only 60 Tablets

Each tablet contains:
Lovastatin, USP 40 mg

Dispense in a tight, light-resistant
container as defined in the USP
using a child-resistant closure.

Keep container tightly closed.

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

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

Protect from light.

Usual Adult Dosage: See
accompanying prescribing
information.

Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Mylan.com

RM6540D5

Lovastatin Tablets 40 mg Bottle Labels