Lamotrigine (Page 19 of 19)

PRINCIPAL DISPLAY PANEL — 25 mg

NDC 51079-498-20

Lamotrigine
Tablets, USP
25 mg

100 Tablets (10 x 10)

Each tablet contains:
Lamotrigine, USP 25 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.]
Protect from light and moisture.

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

Rx only

S-10385 R6

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.

Lamotrigine 25 mg Tablets Unit Carton Label
(click image for full-size original)
Unit CartonLamotrigine 25 mg Tablets Unit Carton LabelUnit Carton

PRINCIPAL DISPLAY PANEL — 100 mg

NDC 51079-499-20

Lamotrigine
Tablets, USP
100 mg

100 Tablets (10 x 10)

Each tablet contains:
Lamotrigine, USP 100 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.]
Protect from light and moisture.

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

Rx only

S-10386 R5

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.

Lamotrigine 100 mg Tablets Unit Carton Label
(click image for full-size original)
Unit CartonLamotrigine 100 mg Tablets Unit Carton LabelUnit Carton

PRINCIPAL DISPLAY PANEL — 150 mg

NDC 51079-865-20

Lamotrigine
Tablets, USP
150 mg

100 Tablets (10 x 10)

Each tablet contains:
Lamotrigine, USP 150 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.]
Protect from light and moisture.

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

Rx only

S-10458 R5

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.

Lamotrigine 150 mg Tablets Unit Carton Label
(click image for full-size original)
Unit CartonLamotrigine 150 mg Tablets Unit Carton LabelUnit Carton

PRINCIPAL DISPLAY PANEL — 200 mg

NDC 51079-866-20

Lamotrigine
Tablets, USP
200 mg

100 Tablets (10 x 10)

Each tablet contains:
Lamotrigine, USP 200 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.]
Protect from light and moisture.

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

Rx only

S-10459 R5

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.

Lamotrigine 200 mg Tablets Unit Carton Label
(click image for full-size original)
Unit CartonLamotrigine 200 mg Tablets Unit Carton LabelUnit Carton
LAMOTRIGINE lamotrigine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51079-498(NDC:0378-4251)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LAMOTRIGINE (LAMOTRIGINE) LAMOTRIGINE 25 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
ANHYDROUS LACTOSE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
SODIUM LAURYL SULFATE
Product Characteristics
Color white (white to off-white) Score 2 pieces
Shape ROUND Size 6mm
Flavor Imprint Code M;L;51
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51079-498-20 100 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (51079-498-01)
1 NDC:51079-498-01 1 TABLET in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (51079-498-20)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077420 03/02/2009
LAMOTRIGINE lamotrigine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51079-499(NDC:0378-4252)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LAMOTRIGINE (LAMOTRIGINE) LAMOTRIGINE 100 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
ANHYDROUS LACTOSE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
SODIUM LAURYL SULFATE
Product Characteristics
Color white (white to off-white) Score 2 pieces
Shape ROUND Size 10mm
Flavor Imprint Code M;L52
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51079-499-20 100 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (51079-499-01)
1 NDC:51079-499-01 1 TABLET in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (51079-499-20)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077420 03/02/2009
LAMOTRIGINE lamotrigine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51079-865(NDC:0378-4253)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LAMOTRIGINE (LAMOTRIGINE) LAMOTRIGINE 150 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
ANHYDROUS LACTOSE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
SODIUM LAURYL SULFATE
Product Characteristics
Color white (white to off-white) Score 2 pieces
Shape ROUND Size 11mm
Flavor Imprint Code M;L53
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51079-865-20 100 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (51079-865-01)
1 NDC:51079-865-01 1 TABLET in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (51079-865-20)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077420 06/19/2009
LAMOTRIGINE lamotrigine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51079-866(NDC:0378-4254)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LAMOTRIGINE (LAMOTRIGINE) LAMOTRIGINE 200 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
ANHYDROUS LACTOSE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
SODIUM LAURYL SULFATE
D&C YELLOW NO. 10
FD&C BLUE NO. 1
Product Characteristics
Color green Score 2 pieces
Shape ROUND Size 11mm
Flavor Imprint Code M;L54
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51079-866-20 100 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (51079-866-01)
1 NDC:51079-866-01 1 TABLET in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (51079-866-20)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077420 06/19/2009
Labeler — Mylan Institutional Inc. (039615992)

Revised: 01/2017 Mylan Institutional Inc.

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