GABITRIL (Page 8 of 8)

Package/Label Display Panel

NDC 63459-402-30
30 Tablets
GABITRIL® (tiagabine hydrochloride) Tablets
2 mg
Rx OnlyMedication Guide Required: Each time GABITRIL is dispensed, give the patient a Medication Guide

image
(click image for full-size original)

Package/Label Display Panel

NDC 63459-404-30
30 Tablets
GABITRIL® (tiagabine hydrochloride) Tablets
4 mg
Rx onlyMedication Guide Required: Each time GABITRIL is dispensed, give the patient a Medication Guide

image
(click image for full-size original)

Package/Label Display Panel

NDC 63459-412-30
30 Tablets
GABITRIL® (tiagabine hydrochloride) Tablets
12 mg
Rx onlyMedication Guide Required: Each time GABITRIL is dispensed, give the patient a Medication Guide

image
(click image for full-size original)

Package/Label Display Panel

NDC 63459-416-30
30 Tablets
GABITRIL® (tiagabine hydrochloride) Tablets
16 mg
Rx onlyMedication Guide Required: Each time GABITRIL is dispensed, give the patient a Medication Guide

image
(click image for full-size original)
GABITRIL tiagabine hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63459-402
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TIAGABINE HYDROCHLORIDE (TIAGABINE) TIAGABINE HYDROCHLORIDE 2 mg
Inactive Ingredients
Ingredient Name Strength
ASCORBIC ACID
SILICON DIOXIDE
CROSPOVIDONE
HYDROGENATED SOYBEAN OIL
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
HYPROMELLOSE, UNSPECIFIED
ANHYDROUS LACTOSE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
STEARIC ACID
TITANIUM DIOXIDE
FD&C YELLOW NO. 6
Product Characteristics
Color orange (orange-peach) Score no score
Shape ROUND Size 5mm
Flavor Imprint Code C;402
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63459-402-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:63459-402-01 100 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020646 04/01/2001
GABITRIL tiagabine hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63459-404
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TIAGABINE HYDROCHLORIDE (TIAGABINE) TIAGABINE HYDROCHLORIDE 4 mg
Inactive Ingredients
Ingredient Name Strength
ASCORBIC ACID
SILICON DIOXIDE
CROSPOVIDONE
HYDROGENATED SOYBEAN OIL
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
HYPROMELLOSE, UNSPECIFIED
ANHYDROUS LACTOSE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
STEARIC ACID
TITANIUM DIOXIDE
D&C YELLOW NO. 10
Product Characteristics
Color yellow Score no score
Shape ROUND Size 6mm
Flavor Imprint Code C;404
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63459-404-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:63459-404-01 100 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020646 04/01/2001
GABITRIL tiagabine hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63459-412
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TIAGABINE HYDROCHLORIDE (TIAGABINE) TIAGABINE HYDROCHLORIDE 12 mg
Inactive Ingredients
Ingredient Name Strength
ASCORBIC ACID
SILICON DIOXIDE
CROSPOVIDONE
HYDROGENATED SOYBEAN OIL
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
HYPROMELLOSE, UNSPECIFIED
ANHYDROUS LACTOSE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
STEARIC ACID
TITANIUM DIOXIDE
D&C YELLOW NO. 10
FD&C BLUE NO. 1
Product Characteristics
Color green Score no score
Shape OVAL (ovaloid) Size 12mm
Flavor Imprint Code C;412
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63459-412-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:63459-412-01 100 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020646 04/01/2001
GABITRIL tiagabine hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63459-416
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TIAGABINE HYDROCHLORIDE (TIAGABINE) TIAGABINE HYDROCHLORIDE 16 mg
Inactive Ingredients
Ingredient Name Strength
ASCORBIC ACID
SILICON DIOXIDE
CROSPOVIDONE
HYDROGENATED SOYBEAN OIL
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
HYPROMELLOSE, UNSPECIFIED
ANHYDROUS LACTOSE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
STEARIC ACID
TITANIUM DIOXIDE
FD&C BLUE NO. 2
Product Characteristics
Color blue Score no score
Shape OVAL (ovaloid) Size 13mm
Flavor Imprint Code C;416
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63459-416-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:63459-416-01 100 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020646 04/01/2001
Labeler — Cephalon, Inc. (183236314)

Revised: 09/2021 Cephalon, Inc.

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