Lamotrigine (Page 13 of 13)

Dist. by:

Par Pharmaceutical

Chestnut Ridge, NY 10977 U.S.A.

Mfg. by:

Par Formulations Private Limited,

9/215, Pudupakkam, Kelambakkam — 603 103.

Made in India

Mfg. Lic. No.: TN00002121

MI484-01-74-03

Revised: 10/2019

PACKAGE LABEL PRINCIPAL DISPLAY PANEL

lamotrigine
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lamotrigine
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lamotrigine
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lamotrigine
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lamotrigine
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lamotrigine
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lamotrigine
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lamotrigine
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lamotrigine
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lamotrigine
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LAMOTRIGINE lamotrigine tablet, orally disintegrating
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49884-484
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
MANNITOL
STARCH, CORN
CROSCARMELLOSE SODIUM
PEPPERMINT
SUCRALOSE
MAGNESIUM STEARATE
SODIUM STEARYL FUMARATE
CELLULOSE, MICROCRYSTALLINE
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 6mm
Flavor Imprint Code NT;123
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49884-484-11 30 TABLET, ORALLY DISINTEGRATING in 1 DOSE PACK None
2 NDC:49884-484-41 14 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK None
3 NDC:49884-484-77 16 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK None
4 NDC:49884-484-93 7 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204158 12/16/2015
LAMOTRIGINE lamotrigine tablet, orally disintegrating
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49884-485
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Lamotrigine (Lamotrigine) Lamotrigine 50 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
MANNITOL
STARCH, CORN
CROSCARMELLOSE SODIUM
PEPPERMINT
SUCRALOSE
MAGNESIUM STEARATE
SODIUM STEARYL FUMARATE
CELLULOSE, MICROCRYSTALLINE
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 8mm
Flavor Imprint Code EP;191
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49884-485-11 30 TABLET, ORALLY DISINTEGRATING in 1 DOSE PACK None
2 NDC:49884-485-41 14 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK None
3 NDC:49884-485-77 16 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK None
4 NDC:49884-485-93 7 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204158 12/16/2015
LAMOTRIGINE lamotrigine tablet, orally disintegrating
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49884-486
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
MANNITOL
STARCH, CORN
PEPPERMINT
SUCRALOSE
MAGNESIUM STEARATE
SODIUM STEARYL FUMARATE
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
FERRIC OXIDE RED
Product Characteristics
Color PINK (PEACH) Score no score
Shape ROUND Size 11mm
Flavor Imprint Code E;432
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49884-486-11 30 TABLET, ORALLY DISINTEGRATING in 1 DOSE PACK None
2 NDC:49884-486-41 14 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK None
3 NDC:49884-486-77 16 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK None
4 NDC:49884-486-93 7 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204158 12/16/2015
LAMOTRIGINE lamotrigine tablet, orally disintegrating
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49884-487
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
MANNITOL
STARCH, CORN
CROSCARMELLOSE SODIUM
PEPPERMINT
SUCRALOSE
MAGNESIUM STEARATE
SODIUM STEARYL FUMARATE
CELLULOSE, MICROCRYSTALLINE
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 14mm
Flavor Imprint Code EP;433
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49884-487-11 30 TABLET, ORALLY DISINTEGRATING in 1 DOSE PACK None
2 NDC:49884-487-41 14 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK None
3 NDC:49884-487-77 16 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204158 12/16/2015
LAMOTRIGINE lamotrigine kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49884-880
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49884-880-99 1 BLISTER PACK in 1 PACKAGE, COMBINATION contains a BLISTER PACK
1 1 KIT in 1 BLISTER PACK This package is contained within the PACKAGE, COMBINATION (49884-880-99)
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 21
Part 2 7
Part 1 of 2
LAMOTRIGINE lamotrigine tablet, orally disintegrating
Product Information
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
MANNITOL
STARCH, CORN
CROSCARMELLOSE SODIUM
PEPPERMINT
SUCRALOSE
MAGNESIUM STEARATE
SODIUM STEARYL FUMARATE
CELLULOSE, MICROCRYSTALLINE
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 6mm
Flavor Imprint Code NT;123
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204158 11/27/2015
Part 2 of 2
LAMOTRIGINE lamotrigine tablet, orally disintegrating
Product Information
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LAMOTRIGINE (LAMOTRIGINE) LAMOTRIGINE 50 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
MANNITOL
STARCH, CORN
CROSCARMELLOSE SODIUM
PEPPERMINT
SUCRALOSE
MAGNESIUM STEARATE
SODIUM STEARYL FUMARATE
CELLULOSE, MICROCRYSTALLINE
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 8mm
Flavor Imprint Code EP;191
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204158 11/27/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204158 11/27/2015
LAMOTRIGINE lamotrigine kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49884-882
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49884-882-99 1 BLISTER PACK in 1 PACKAGE, COMBINATION contains a BLISTER PACK
1 1 KIT in 1 BLISTER PACK This package is contained within the PACKAGE, COMBINATION (49884-882-99)
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 14
Part 2 14
Part 3 7
Part 1 of 3
LAMOTRIGINE lamotrigine tablet, orally disintegrating
Product Information
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
MANNITOL
STARCH, CORN
CROSCARMELLOSE SODIUM
PEPPERMINT
MAGNESIUM STEARATE
SUCRALOSE
SODIUM STEARYL FUMARATE
CELLULOSE, MICROCRYSTALLINE
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 6mm
Flavor Imprint Code NT;123
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204158 11/27/2015
Part 2 of 3
LAMOTRIGINE lamotrigine tablet, orally disintegrating
Product Information
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LAMOTRIGINE (LAMOTRIGINE) LAMOTRIGINE 50 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
MANNITOL
STARCH, CORN
CROSCARMELLOSE SODIUM
PEPPERMINT
MAGNESIUM STEARATE
SUCRALOSE
SODIUM STEARYL FUMARATE
CELLULOSE, MICROCRYSTALLINE
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 8mm
Flavor Imprint Code EP;191
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204158 11/27/2015
Part 3 of 3
LAMOTRIGINE lamotrigine tablet, orally disintegrating
Product Information
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
MANNITOL
STARCH, CORN
CROSCARMELLOSE SODIUM
PEPPERMINT
MAGNESIUM STEARATE
SUCRALOSE
SODIUM STEARYL FUMARATE
CELLULOSE, MICROCRYSTALLINE
FERRIC OXIDE RED
Product Characteristics
Color PINK (PEACH) Score no score
Shape ROUND Size 11mm
Flavor Imprint Code E;432
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204158 11/27/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204158 11/27/2015
LAMOTRIGINE lamotrigine kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49884-881
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49884-881-99 1 BLISTER PACK in 1 PACKAGE, COMBINATION contains a BLISTER PACK
1 1 KIT in 1 BLISTER PACK This package is contained within the PACKAGE, COMBINATION (49884-881-99)
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 42
Part 2 14
Part 1 of 2
LAMOTRIGINE lamotrigine tablet, orally disintegrating
Product Information
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LAMOTRIGINE (LAMOTRIGINE) LAMOTRIGINE 50 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
MANNITOL
STARCH, CORN
CROSCARMELLOSE SODIUM
PEPPERMINT
MAGNESIUM STEARATE
SUCRALOSE
SODIUM STEARYL FUMARATE
CELLULOSE, MICROCRYSTALLINE
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 8mm
Flavor Imprint Code EP;191
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204158 11/27/2015
Part 2 of 2
LAMOTRIGINE lamotrigine tablet, orally disintegrating
Product Information
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
MANNITOL
STARCH, CORN
CROSCARMELLOSE SODIUM
PEPPERMINT
MAGNESIUM STEARATE
SUCRALOSE
SODIUM STEARYL FUMARATE
CELLULOSE, MICROCRYSTALLINE
FERRIC OXIDE RED
Product Characteristics
Color PINK (PEACH) Score no score
Shape ROUND Size 11mm
Flavor Imprint Code E;432
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204158 11/27/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204158 11/27/2015
Labeler — Par Pharmaceutical, Inc. (092733690)

Revised: 10/2019 Par Pharmaceutical, Inc.

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