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

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

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

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

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.