Gabapentin (Page 7 of 7)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

800mg
(click image for full-size original)
600mg
(click image for full-size original)
GABAPENTIN gabapentin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76267-150
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
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED
HYDROXYPROPYL CELLULOSE
MANNITOL
COPOVIDONE
TALC
POLOXAMER 407
MAGNESIUM STEARATE
TITANIUM DIOXIDE
POLYVINYL ALCOHOL
POLYETHYLENE GLYCOLS
Product Characteristics
Color WHITE (White to off-white) Score 2 pieces
Shape OVAL (Whit to off-white oval shaped film coated tablets deep scoring on both the sides) Size 18mm
Flavor Imprint Code NT;150
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76267-150-02 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203244 06/02/2013
GABAPENTIN gabapentin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76267-151
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
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED
HYDROXYPROPYL CELLULOSE
MANNITOL
COPOVIDONE
TALC
POLOXAMER 407
MAGNESIUM STEARATE
POLYVINYL ALCOHOL
TITANIUM DIOXIDE
POLYETHYLENE GLYCOLS
Product Characteristics
Color WHITE (White to off-white) Score 2 pieces
Shape OVAL (Whit to off-white oval shaped film coated tablets deep scoring on both the sides) Size 19mm
Flavor Imprint Code NT;151
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76267-151-02 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203244 06/02/2013
Labeler — Allied Pharma Inc (965727683)
Establishment
Name Address ID/FEI Operations
Par Formulations Private Limited 676159161 MANUFACTURE (76267-150), MANUFACTURE (76267-151)

Revised: 08/2013 Allied Pharma Inc

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