Gabapentin: Package Insert and Label Information (Page 5 of 5)

Manufactured by:
Amneal Pharmaceuticals of NY
Hauppauge, NY 11788

Distributed by:
Amneal Pharmaceuticals
Glasgow, KY 42141

Rev. 10-2011

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Gabapentin Capsules
100 mg
100 mg package label
(click image for full-size original)

300 mg
300 mg package label
(click image for full-size original)

400 mg
400 mg package label
(click image for full-size original)
GABAPENTIN gabapentin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-5226(NDC:53746-101)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GABAPENTIN (GABAPENTIN) GABAPENTIN 100 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE
STARCH, CORN
TALC
GELATIN
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
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:54868-5226-0 100 CAPSULE (CAPSULE) in 1 BOTTLE None
2 NDC:54868-5226-1 30 CAPSULE (CAPSULE) in 1 BOTTLE None
3 NDC:54868-5226-2 60 CAPSULE (CAPSULE) in 1 BOTTLE None
4 NDC:54868-5226-3 90 CAPSULE (CAPSULE) in 1 BOTTLE None
5 NDC:54868-5226-5 150 CAPSULE (CAPSULE) in 1 BOTTLE None
6 NDC:54868-5226-6 270 CAPSULE (CAPSULE) in 1 BOTTLE None
7 NDC:54868-5226-7 120 CAPSULE (CAPSULE) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078428 09/24/2009
GABAPENTIN gabapentin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-5166(NDC:53746-102)
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
MAGNESIUM STEARATE
STARCH, CORN
TALC
GELATIN
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
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:54868-5166-0 60 CAPSULE (CAPSULE) in 1 BOTTLE None
2 NDC:54868-5166-1 100 CAPSULE (CAPSULE) in 1 BOTTLE None
3 NDC:54868-5166-2 30 CAPSULE (CAPSULE) in 1 BOTTLE None
4 NDC:54868-5166-3 90 CAPSULE (CAPSULE) in 1 BOTTLE None
5 NDC:54868-5166-4 20 CAPSULE (CAPSULE) in 1 BOTTLE None
6 NDC:54868-5166-5 120 CAPSULE (CAPSULE) in 1 BOTTLE None
7 NDC:54868-5166-6 270 CAPSULE (CAPSULE) in 1 BOTTLE None
8 NDC:54868-5166-7 180 CAPSULE (CAPSULE) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078428 08/29/2006
GABAPENTIN gabapentin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-5901(NDC:53746-103)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GABAPENTIN (GABAPENTIN) GABAPENTIN 400 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE
STARCH, CORN
TALC
GELATIN
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
FD&C YELLOW NO. 6
FD&C BLUE NO. 1
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:54868-5901-0 60 CAPSULE (CAPSULE) in 1 BOTTLE None
2 NDC:54868-5901-1 90 CAPSULE (CAPSULE) in 1 BOTTLE None
3 NDC:54868-5901-2 100 CAPSULE (CAPSULE) in 1 BOTTLE None
4 NDC:54868-5901-3 30 CAPSULE (CAPSULE) in 1 BOTTLE None
5 NDC:54868-5901-4 120 CAPSULE (CAPSULE) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078428 11/07/2008
Labeler — Physicians Total Care, Inc. (194123980)
Establishment
Name Address ID/FEI Operations
Physicians Total Care, Inc. 194123980 relabel, repack

Revised: 06/2012 Physicians Total Care, Inc.

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