Gabapentin (Page 8 of 8)

PRINCIPAL DISPLAY PANEL

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PRINCIPAL DISPLAY PANEL

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GABAPENTIN
gabapentin tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68462-126
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GABAPENTIN (GABAPENTIN) GABAPENTIN 600 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
COPOVIDONE K25-31
POLOXAMER 407
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
HYPROMELLOSE, UNSPECIFIED
TITANIUM DIOXIDE
TALC
POLYSORBATE 80
WATER
Product Characteristics
Color WHITE (White to off-white) Score 2 pieces
Shape OVAL Size 17mm
Flavor Imprint Code G;31
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68462-126-01 100 TABLET in 1 BOTTLE None
2 NDC:68462-126-05 500 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077662 04/01/2006
GABAPENTIN
gabapentin tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68462-127
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GABAPENTIN (GABAPENTIN) GABAPENTIN 800 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
COPOVIDONE K25-31
POLOXAMER 407
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
HYPROMELLOSE, UNSPECIFIED
TITANIUM DIOXIDE
TALC
POLYSORBATE 80
WATER
Product Characteristics
Color WHITE (White to off-white) Score 2 pieces
Shape OVAL Size 19mm
Flavor Imprint Code G;13
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68462-127-01 100 TABLET in 1 BOTTLE None
2 NDC:68462-127-05 500 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077662 04/01/2006
Labeler — Glenmark Pharmaceuticals Inc., USA (130597813)
Establishment
Name Address ID/FEI Operations
Glenmark Pharmaceuticals Limited 677318665 MANUFACTURE (68462-126), MANUFACTURE (68462-127), ANALYSIS (68462-126), ANALYSIS (68462-127)
Establishment
Name Address ID/FEI Operations
Glenmark Pharmaceuticals Limited 862603186 MANUFACTURE (68462-126), MANUFACTURE (68462-127), ANALYSIS (68462-126), ANALYSIS (68462-127)
Establishment
Name Address ID/FEI Operations
Appco Pharma LLC, USA (Unit-II) 078510186 MANUFACTURE (68462-126), MANUFACTURE (68462-127), ANALYSIS (68462-126), ANALYSIS (68462-127)

Revised: 02/2021 Glenmark Pharmaceuticals Inc., USA

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