Gabapentin (Page 10 of 10)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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GABAPENTIN
gabapentin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58517-060
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GABAPENTIN (GABAPENTIN) GABAPENTIN 300 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
TALC
GELATIN
TITANIUM DIOXIDE
SODIUM LAURYL SULFATE
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
SHELLAC
Product Characteristics
Color YELLOW Score no score
Shape CAPSULE Size 20mm
Flavor Imprint Code D;03
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58517-060-30 30 CAPSULE (CAPSULE) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078787 08/25/2013
Labeler — New Horizon Rx Group, LLC (056256127)
Registrant — New Horizon Rx Group, LLC (056256127)
Establishment
Name Address ID/FEI Operations
Aurobindo Pharma Limited 650381903 MANUFACTURE (58517-060)

Revised: 12/2013 New Horizon Rx Group, LLC

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