Lamotrigine Extended Release (Page 11 of 11)

PRINCIPAL DISPLAY PANEL

25 mg-30s
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PRINCIPAL DISPLAY PANEL

50 mg-30s
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PRINCIPAL DISPLAY PANEL

100 mg-30s
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PRINCIPAL DISPLAY PANEL

200 mg-30s
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PRINCIPAL DISPLAY PANEL

250 mg-30s
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PRINCIPAL DISPLAY PANEL

300 mg-30s
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LAMOTRIGINE EXTENDED RELEASE
lamotrigine extended release tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49884-561
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
METHACRYLIC ACID
HYPROMELLOSES
SILICON DIOXIDE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
Product Characteristics
Color BROWN (BEIGE) Score no score
Shape ROUND Size 9mm
Flavor Imprint Code Par;561
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49884-561-01 100 TABLET in 1 BOTTLE None
2 NDC:49884-561-05 500 TABLET in 1 BOTTLE None
3 NDC:49884-561-11 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201791 01/18/2013
LAMOTRIGINE EXTENDED RELEASE
lamotrigine extended release tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49884-562
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
METHACRYLIC ACID
HYPROMELLOSES
SILICON DIOXIDE
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 9mm
Flavor Imprint Code Par;562
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49884-562-01 100 TABLET in 1 BOTTLE None
2 NDC:49884-562-05 500 TABLET in 1 BOTTLE None
3 NDC:49884-562-11 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201791 01/18/2013
LAMOTRIGINE EXTENDED RELEASE
lamotrigine extended release tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49884-563
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
METHACRYLIC ACID
HYPROMELLOSES
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
Product Characteristics
Color BROWN Score no score
Shape ROUND Size 10mm
Flavor Imprint Code Par;563
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49884-563-01 100 TABLET in 1 BOTTLE None
2 NDC:49884-563-05 500 TABLET in 1 BOTTLE None
3 NDC:49884-563-11 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201791 01/18/2013
LAMOTRIGINE EXTENDED RELEASE
lamotrigine extended release tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49884-564
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
METHACRYLIC ACID
HYPROMELLOSES
SILICON DIOXIDE
Product Characteristics
Color YELLOW Score no score
Shape ROUND Size 10mm
Flavor Imprint Code Par;564
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49884-564-01 100 TABLET in 1 BOTTLE None
2 NDC:49884-564-05 500 TABLET in 1 BOTTLE None
3 NDC:49884-564-11 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201791 01/18/2013
LAMOTRIGINE EXTENDED RELEASE
lamotrigine extended release tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49884-604
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LAMOTRIGINE (LAMOTRIGINE) LAMOTRIGINE 250 mg
Inactive Ingredients
Ingredient Name Strength
METHACRYLIC ACID
HYPROMELLOSES
SILICON DIOXIDE
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 10mm
Flavor Imprint Code Par;604
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49884-604-01 100 TABLET in 1 BOTTLE None
2 NDC:49884-604-05 500 TABLET in 1 BOTTLE None
3 NDC:49884-604-11 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201791 01/18/2013
LAMOTRIGINE EXTENDED RELEASE
lamotrigine extended release tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49884-605
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LAMOTRIGINE (LAMOTRIGINE) LAMOTRIGINE 300 mg
Inactive Ingredients
Ingredient Name Strength
FERROSOFERRIC OXIDE
METHACRYLIC ACID
HYPROMELLOSES
SILICON DIOXIDE
Product Characteristics
Color GRAY Score no score
Shape ROUND Size 10mm
Flavor Imprint Code Par;605
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49884-605-01 100 TABLET in 1 BOTTLE None
2 NDC:49884-605-05 500 TABLET in 1 BOTTLE None
3 NDC:49884-605-11 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201791 01/18/2013
Labeler — Par Pharmaceutical, Inc. (092733690)
Establishment
Name Address ID/FEI Operations
Zhejiang Huahai Pharmaceutical Co., Ltd. 530732460 ANALYSIS (49884-561), ANALYSIS (49884-562), ANALYSIS (49884-563), ANALYSIS (49884-564), ANALYSIS (49884-604), ANALYSIS (49884-605), MANUFACTURE (49884-561), MANUFACTURE (49884-562), MANUFACTURE (49884-563), MANUFACTURE (49884-564), MANUFACTURE (49884-604), MANUFACTURE (49884-605), PACK (49884-561), PACK (49884-562), PACK (49884-563), PACK (49884-564), PACK (49884-604), PACK (49884-605)

Revised: 10/2019 Par Pharmaceutical, Inc.

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