Gabapentin (Page 6 of 6)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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GABAPENTIN gabapentin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68387-420(NDC:53746-101)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GABAPENTIN (GABAPENTIN) GABAPENTIN 100 mg
Product Characteristics
Color WHITE (WHITE) Score no score
Shape CAPSULE (HARD GELATIN) Size 16mm
Flavor Imprint Code IP101
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68387-420-30 30 CAPSULE (CAPSULE) in 1 BOTTLE, PLASTIC None
2 NDC:68387-420-90 90 CAPSULE (CAPSULE) in 1 BOTTLE, PLASTIC None
3 NDC:68387-420-12 120 CAPSULE (CAPSULE) in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078428 12/15/2009
GABAPENTIN gabapentin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68387-410(NDC:53746-102)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GABAPENTIN (GABAPENTIN) GABAPENTIN 300 mg
Product Characteristics
Color YELLOW (Buff-Buff) Score no score
Shape CAPSULE (HARD GELATIN) Size 19mm
Flavor Imprint Code IP102
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68387-410-30 30 CAPSULE (CAPSULE) in 1 BOTTLE, PLASTIC None
2 NDC:68387-410-60 60 CAPSULE (CAPSULE) in 1 BOTTLE, PLASTIC None
3 NDC:68387-410-90 90 CAPSULE (CAPSULE) in 1 BOTTLE, PLASTIC None
4 NDC:68387-410-18 180 CAPSULE (CAPSULE) in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078428 12/15/2009
GABAPENTIN gabapentin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68387-404(NDC:53746-103)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GABAPENTIN (GABAPENTIN) GABAPENTIN 400 mg
Product Characteristics
Color BROWN (Light caramel-Light caramel) Score no score
Shape CAPSULE (HARD GELATIN) Size 21mm
Flavor Imprint Code IP103
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68387-404-60 60 CAPSULE (CAPSULE) in 1 BOTTLE, PLASTIC None
2 NDC:68387-404-90 90 CAPSULE (CAPSULE) in 1 BOTTLE, PLASTIC None
3 NDC:68387-404-12 120 CAPSULE (CAPSULE) in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078428 12/15/2009
Labeler — Keltman Pharmaceuticals Inc. (362861077)
Establishment
Name Address ID/FEI Operations
Keltman Pharmaceuticals Inc. 362861077 repack, relabel

Revised: 02/2011 Keltman Pharmaceuticals Inc.

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