Oxcarbazepine (Page 8 of 8)

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OXCARBAZEPINE oxcarbazepine tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68462-137
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OXCARBAZEPINE (OXCARBAZEPINE) OXCARBAZEPINE 150 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSPOVIDONE (35 .MU.M)
FERRIC OXIDE YELLOW
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
MEGLUMINE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
TITANIUM DIOXIDE
Product Characteristics
Color YELLOW Score 2 pieces
Shape OVAL Size 11mm
Flavor Imprint Code G;13;and;7
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68462-137-01 100 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:68462-137-05 500 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077802 10/09/2007
OXCARBAZEPINE oxcarbazepine tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68462-138
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OXCARBAZEPINE (OXCARBAZEPINE) OXCARBAZEPINE 300 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSPOVIDONE (35 .MU.M)
FERRIC OXIDE YELLOW
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
MEGLUMINE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
TITANIUM DIOXIDE
Product Characteristics
Color YELLOW Score 2 pieces
Shape OVAL Size 15mm
Flavor Imprint Code G;4
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68462-138-01 100 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:68462-138-05 500 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077802 10/09/2007
OXCARBAZEPINE oxcarbazepine tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68462-139
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OXCARBAZEPINE (OXCARBAZEPINE) OXCARBAZEPINE 600 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSPOVIDONE (35 .MU.M)
FERRIC OXIDE YELLOW
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
MEGLUMINE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
TITANIUM DIOXIDE
Product Characteristics
Color YELLOW Score 2 pieces
Shape OVAL Size 19mm
Flavor Imprint Code G;13;and;9
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68462-139-01 100 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:68462-139-05 500 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077802 10/09/2007
Labeler — Glenmark Pharmaceuticals Inc., USA (130597813)
Establishment
Name Address ID/FEI Operations
Glenmark Pharmaceuticals Limited 862603186 ANALYSIS (68462-137), ANALYSIS (68462-138), ANALYSIS (68462-139), MANUFACTURE (68462-137), MANUFACTURE (68462-138), MANUFACTURE (68462-139)
Establishment
Name Address ID/FEI Operations
Glenmark Pharmaceuticals Limited 677318665 MANUFACTURE (68462-137), MANUFACTURE (68462-138), MANUFACTURE (68462-139), ANALYSIS (68462-137), ANALYSIS (68462-138), ANALYSIS (68462-139)

Revised: 08/2019 Glenmark Pharmaceuticals Inc., USA

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