Levetiracetam (Page 14 of 14)

PRINCIPAL DISPLAY PANEL – 250 mg

NDC 0378-5613-78

Levetiracetam
Tablets, USP
250 mg

PHARMACIST: Dispense the accompanying
Medication Guide to each patient.

Rx only 120 Tablets

Each film-coated tablet contains:
Levetiracetam, USP 250 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.]

Usual Dosage: See accompanying
prescribing information.

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

Mylan.com

RM5613DA5

Levetiracetam Tablets, USP 250 mg Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL – 500 mg

NDC 0378-5615-78

Levetiracetam
Tablets, USP
500 mg

PHARMACIST: Dispense the accompanying
Medication Guide to each patient.

Rx only 120 Tablets

Each film-coated tablet contains:
Levetiracetam, USP 500 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.]

Usual Dosage: See accompanying
prescribing information.

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

Mylan.com

RM5615DA5

Levetiracetam Tablets, USP 500 mg Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL – 750 mg

NDC 0378-5617-78

Levetiracetam
Tablets, USP
750 mg

PHARMACIST: Dispense the accompanying
Medication Guide to each patient.

Rx only 120 Tablets

Each film-coated tablet contains:
Levetiracetam, USP 750 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.]

Usual Dosage: See accompanying
prescribing information.

This container is not intended for
dispensing for household use.

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

Mylan.com

RM5617DA5

Levetiracetam Tablets, USP 750 mg Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL – 1000 mg

NDC 0378-5619-91

Levetiracetam
Tablets, USP
1000 mg

PHARMACIST: Dispense the accompanying
Medication Guide to each patient.

Rx only 60 Tablets

Each film-coated tablet contains:
Levetiracetam, USP 1000 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.]

Usual Dosage: See accompanying
prescribing information.

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

Mylan.com

RM5619DA5

Levetiracetam Tablets, USP 1000 mg Bottle Label
(click image for full-size original)
LEVETIRACETAM levetiracetam tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-5613
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVETIRACETAM (LEVETIRACETAM) LEVETIRACETAM 250 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYDEXTROSE
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE, UNSPECIFIED
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
TRIACETIN
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 10mm
Flavor Imprint Code M;613
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0378-5613-78 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
2 NDC:0378-5613-05 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076919 11/04/2008
LEVETIRACETAM levetiracetam tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-5615
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVETIRACETAM (LEVETIRACETAM) LEVETIRACETAM 500 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYDEXTROSE
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE, UNSPECIFIED
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
TRIACETIN
Product Characteristics
Color WHITE Score 2 pieces
Shape OVAL (modified capsule-shaped) Size 17mm
Flavor Imprint Code M;615
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0378-5615-78 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
2 NDC:0378-5615-05 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076919 11/04/2008
LEVETIRACETAM levetiracetam tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-5617
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVETIRACETAM (LEVETIRACETAM) LEVETIRACETAM 750 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYDEXTROSE
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE, UNSPECIFIED
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
TRIACETIN
Product Characteristics
Color WHITE Score 2 pieces
Shape OVAL (modified capsule-shaped) Size 19mm
Flavor Imprint Code M;617
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0378-5617-78 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
2 NDC:0378-5617-05 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076919 11/04/2008
LEVETIRACETAM levetiracetam tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-5619
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVETIRACETAM (LEVETIRACETAM) LEVETIRACETAM 1000 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYDEXTROSE
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE, UNSPECIFIED
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
TRIACETIN
Product Characteristics
Color WHITE Score 2 pieces
Shape OVAL (modified capsule-shaped) Size 21mm
Flavor Imprint Code M;619
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0378-5619-91 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090261 12/10/2009
Labeler — Mylan Pharmaceuticals Inc. (059295980)

Revised: 02/2020 Mylan Pharmaceuticals Inc.

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