LAMOTRIGINE Kit (Page 12 of 12)

PRINCIPAL DISPLAY PANEL — 25 mg Starter Kit

Blue Starter Kit
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PRINCIPAL DISPLAY PANEL — 25 mg, 100 mg Starter Kit

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LAMOTRIGINE KIT lamotrigine kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69102-137
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69102-137-10 7 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 (69102-137-10)
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 7
Part 2 42
Part 1 of 2
LAMOTRIGINE lamotrigine tablet
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
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POVIDONE K30
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color white (white to off white) Score 2 pieces
Shape ROUND (Round, flat face beveled edge) Size 9mm
Flavor Imprint Code 1047
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078947 08/30/2017
Part 2 of 2
LAMOTRIGINE lamotrigine tablet
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
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POVIDONE K30
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color white (white to off white) Score 2 pieces
Shape ROUND (Round, flat face beveled edge) Size 6mm
Flavor Imprint Code 45
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078947 08/30/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078947 08/30/2017
LAMOTRIGINE KIT lamotrigine kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69102-359
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69102-359-11 14 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 (69102-359-11)
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 14
Part 2 84
Part 1 of 2
LAMOTRIGINE lamotrigine tablet
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
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POVIDONE K30
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color white (white to off white) Score 2 pieces
Shape ROUND (Round, flat face beveled edge) Size 9mm
Flavor Imprint Code 1047
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078947 08/30/2017
Part 2 of 2
LAMOTRIGINE lamotrigine tablet
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
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POVIDONE K30
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color white (white to off white) Score 2 pieces
Shape ROUND (Round, flat face beveled edge) Size 6mm
Flavor Imprint Code 45
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078947 08/30/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078947 08/30/2017
LAMOTRIGINE lamotrigine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69102-639
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
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POVIDONE K30
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color white (white to off white) Score 2 pieces
Shape ROUND (Round, flat face beveled edge) Size 6mm
Flavor Imprint Code 45
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69102-639-09 35 TABLET in 1 DOSE PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078947 08/30/2017
Labeler — OWP Pharmaceuticals, Inc. (079392532)
Establishment
Name Address ID/FEI Operations
Torrent Pharmaceuticals Limited 916488547 manufacture (69102-137), manufacture (69102-359), manufacture (69102-639)

Revised: 11/2019 OWP Pharmaceuticals, Inc.

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