GABAPENTIN (Page 7 of 7)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

25000-103-03
Rx only
Gabapentin Capsules, USP
100mg
30 Capsules

gaba100mg-30s-bott
(click image for full-size original)

PACKAGE LABEL PRINCIPAL DISPLAY PANEL
25000-103-12
Rx only
Gabapentin Capsules, USP
100mg 500 Capsules

gaba100mg-500s-bott
(click image for full-size original)

25000-103-14
Rx only
Gabapentin Capsules, USP
100mg 1000 Capsules

gaba100mg1000cap
(click image for full-size original)



25000-104-03
Rx only
Gabapentin Capsules, USP
300mg 30 Capsules

gaba300mg-30s-bott
(click image for full-size original)

PACKAGE LABEL PRINCIPAL DISPLAY PANEL
25000-104-12
Rx only
Gabapentin Capsules, USP
300mg 500 Capsules

gaba300mg-500s-bott
(click image for full-size original)

25000-104-14
Rx only
Gabapentin Capsules, USP
300mg 1000 Capsules

gaba300mg1000cap
(click image for full-size original)

25000-105-03
Rx only
Gabapentin Capsules, USP
400mg 30 Capsules

gaba400mg-30s-bott
(click image for full-size original)

PACKAGE LABEL PRINCIPAL DISPLAY PANEL
25000-105-12
Rx only
Gabapentin Capsules, USP
400mg 500 Capsules

gaba400mg-500s-bott
(click image for full-size original)

25000-105-14
Rx only
Gabapentin Capsules, USP
400mg 1000 Capsules

gaba400mg1000cap
(click image for full-size original)
GABAPENTIN gabapentin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:25000-103
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
LACTOSE MONOHYDRATE
STARCH, CORN
TALC
GELATIN
TITANIUM DIOXIDE
PROPYLENE GLYCOL
SHELLAC
FD&C BLUE NO. 1 ALUMINUM LAKE
Product Characteristics
Color WHITE Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code 103
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:25000-103-03 30 CAPSULE in 1 BOTTLE None
2 NDC:25000-103-12 500 CAPSULE in 1 BOTTLE None
3 NDC:25000-103-01 4000 CAPSULE in 1 BAG None
4 NDC:25000-103-98 1 BAG in 1 BOX contains a BAG
4 55555 CAPSULE in 1 BAG This package is contained within the BOX (25000-103-98)
5 NDC:25000-103-92 1 BAG in 1 BOX contains a BAG
5 38888 CAPSULE in 1 BAG This package is contained within the BOX (25000-103-92)
6 NDC:25000-103-14 1000 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090007 02/28/2011
GABAPENTIN gabapentin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:25000-104
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
LACTOSE MONOHYDRATE
STARCH, CORN
TALC
GELATIN
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
PROPYLENE GLYCOL
SHELLAC
FD&C BLUE NO. 1 ALUMINUM LAKE
Product Characteristics
Color YELLOW Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code 104
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:25000-104-03 30 CAPSULE in 1 BOTTLE None
2 NDC:25000-104-12 500 CAPSULE in 1 BOTTLE None
3 NDC:25000-104-27 2500 CAPSULE in 1 BAG None
4 NDC:25000-104-92 1 BAG in 1 BOX contains a BAG
4 15020 CAPSULE in 1 BAG This package is contained within the BOX (25000-104-92)
5 NDC:25000-104-14 1000 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090007 02/28/2011
GABAPENTIN gabapentin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:25000-105
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
LACTOSE MONOHYDRATE
STARCH, CORN
TALC
GELATIN
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
PROPYLENE GLYCOL
SHELLAC
FERRIC OXIDE RED
FD&C BLUE NO. 1 ALUMINUM LAKE
Product Characteristics
Color ORANGE Score no score
Shape CAPSULE Size 21mm
Flavor Imprint Code 105
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:25000-105-03 30 CAPSULE in 1 BOTTLE None
2 NDC:25000-105-12 500 CAPSULE in 1 BOTTLE None
3 NDC:25000-105-42 1700 CAPSULE in 1 BAG None
4 NDC:25000-105-91 1 BAG in 1 BOX contains a BAG
4 8115 CAPSULE in 1 BAG This package is contained within the BOX (25000-105-91)
5 NDC:25000-105-14 1000 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090007 02/28/2011
Labeler — MARKSANS PHARMA LIMITED (925822975)
Establishment
Name Address ID/FEI Operations
MARKSANS PHARMA LIMITED 925822975 MANUFACTURE (25000-103), MANUFACTURE (25000-104), MANUFACTURE (25000-105)

Revised: 09/2021 MARKSANS PHARMA LIMITED

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