Tiagabine Hydrochloride (Page 8 of 8)

Package/Label Display Panel

NDC 0093-5030 -56
Tiagabine Hydrochloride Tablets
2 mg
Medication Guide Required: Each time tiagabine hydrochloride tablets are dispensed, give the patient a Medication Guide.
Rx only
30 Tablets teva

image
(click image for full-size original)

Package/Label Display Panel

NDC 0093-5031 -56
Tiagabine Hydrochloride Tablets
4 mg
Medication Guide Required: Each time tiagabine hydrochloride tablets are dispensed, give the patient a Medication Guide.
Rx only
30 Tablets teva

image
(click image for full-size original)

Package/Label Display Panel

NDC 0 093-8072 -56

Tiagabine Hydrochloride Tablets

12 mg

Medication Guide Required: Each time tiagabine hydrochloride tablets are dispensed, give the patient a Medication Guide.

Rx only

30 Tablets

teva

image
(click image for full-size original)

Package/Label Display Panel

NDC 0093-8076 -56

Tiagabine Hydrochloride Tablets

16 mg

Medication Guide Required: Each time tiagabine hydrochloride tablets are dispensed, give the patient a Medication Guide.

Rx only

30 Tablets

teva

image
(click image for full-size original)
TIAGABINE HYDROCHLORIDE tiagabine hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-5030
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
MICROCRYSTALLINE CELLULOSE
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:0093-5030-56 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA020646 06/03/2016
TIAGABINE HYDROCHLORIDE tiagabine hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-5031
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
MICROCRYSTALLINE CELLULOSE
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:0093-5031-56 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA020646 06/03/2016
TIAGABINE HYDROCHLORIDE tiagabine hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-8072
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
MICROCRYSTALLINE CELLULOSE
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:0093-8072-56 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA020646 03/09/2018
TIAGABINE HYDROCHLORIDE tiagabine hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-8076
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
MICROCRYSTALLINE CELLULOSE
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:0093-8076-56 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA020646 03/09/2018
Labeler — Teva Pharmaceuticals USA, Inc. (001627975)

Revised: 09/2021 Teva Pharmaceuticals USA, Inc.

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