Levetiracetam (Page 15 of 15)

PRINCIPAL DISPLAY PANEL — 250 mg

NDC 51079-820-20

Levetiracetam
Tablets, USP
250 mg

100 Tablets (10 x 10)

Each film-coated tablet contains:
Levetiracetam, USP 250 mg

Usual Dosage: See accompanying
prescribing information and
Medication Guide.

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

Code No.: UP/DRUG/14/74

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

Made in India

Rx only

S-12295

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.

Levetiracetam 250 mg Tablet Unit Carton Label
(click image for full-size original)
Serialized Unit CartonLevetiracetam 250 mg Tablet Unit Carton LabelSerialized Unit Carton

PRINCIPAL DISPLAY PANEL — 500 mg

NDC 51079-821-20

Levetiracetam
Tablets, USP
500 mg

100 Tablets (10 x 10)

Each film-coated tablet contains:
Levetiracetam, USP 500 mg

Usual Dosage: See accompanying
prescribing information and
Medication Guide.

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

Code No.: UP/DRUG/14/74

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

Made in India

Rx only

S-12258

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.

Levetiracetam 500 mg Tablet Unit Carton Label
(click image for full-size original)
Serialized Unit Carton Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 750 mg

NDC 51079-822-20

Levetiracetam
Tablets, USP
750 mg

100 Tablets (10 x 10)

Each film-coated tablet contains:
Levetiracetam, USP 750 mg

Usual Dosage: See accompanying
prescribing information and
Medication Guide.

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

Code No.: UP/DRUG/14/74

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

Made in India

Rx only

S-12296

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.

Levetiracetam 750 mg Tablet Unit Carton Label
(click image for full-size original)
Serialized Unit Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 1000 mg

NDC 51079-860-06

Levetiracetam
Tablets, USP
1000 mg

50 Tablets (5 x 10)

Each film-coated tablet contains:
Levetiracetam, USP 1000 mg

Usual Dosage: See accompanying
prescribing information and
Medication Guide.

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

Code No.: UP/DRUG/14/74

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

Made in India

Rx only

S-12297

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.

Levetiracetam 1000 mg Tablet Unit Carton Label
(click image for full-size original)
Serialized Unit Carton
(click image for full-size original)
LEVETIRACETAM levetiracetam tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51079-820(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:51079-820-20 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK (51079-820-01)
1 NDC:51079-820-01 1 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (51079-820-20)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076919 11/04/2008 11/30/2019
LEVETIRACETAM levetiracetam tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51079-821(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:51079-821-20 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK (51079-821-01)
1 NDC:51079-821-01 1 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (51079-821-20)
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:51079-822(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
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYDEXTROSE
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE, UNSPECIFIED
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
TRIACETIN
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
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:51079-822-20 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK (51079-822-01)
1 NDC:51079-822-01 1 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (51079-822-20)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076919 11/04/2008 05/31/2020
LEVETIRACETAM levetiracetam tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51079-860(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:51079-860-06 50 BLISTER PACK in 1 CARTON contains a BLISTER PACK (51079-860-01)
1 NDC:51079-860-01 1 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (51079-860-06)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090261 03/24/2010 07/31/2020
Labeler — Mylan Institutional Inc. (039615992)

Revised: 12/2019 Mylan Institutional Inc.

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