NDC Code(s) : 55253-600-30, 55253-601-30
Packager : CIMA LABS INC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Tiagabine HydrochlorideTiagabine Hydrochloride TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55253-600
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TIAGABINE HYDROCHLORIDE(UNII: DQH6T6D8OY)
(TIAGABINE - UNII:Z80I64HMNP) 		TIAGABINE HYDROCHLORIDE2 mg
Inactive Ingredients
Ingredient Name Strength
ASCORBIC ACID(UNII: PQ6CK8PD0R)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSPOVIDONE, UNSPECIFIED(UNII: 2S7830E561)
HYDROGENATED SOYBEAN OIL(UNII: A2M91M918C)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(UNII: 9XZ8H6N6OH)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
STARCH, CORN(UNII: O8232NY3SJ)
STEARIC ACID(UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
Product Characteristics
Color ORANGE (orange-peach) Score no score
Shape ROUND Size 5 mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55253-600-3030 in 1 BOTTLE Type 0: Not a Combination Product21/12/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA020646 12/21/2012 05/31/2017
Tiagabine HydrochlorideTiagabine Hydrochloride TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55253-601
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TIAGABINE HYDROCHLORIDE(UNII: DQH6T6D8OY)
(TIAGABINE - UNII:Z80I64HMNP) 		TIAGABINE HYDROCHLORIDE4 mg
Inactive Ingredients
Ingredient Name Strength
ASCORBIC ACID(UNII: PQ6CK8PD0R)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSPOVIDONE, UNSPECIFIED(UNII: 2S7830E561)
HYDROGENATED SOYBEAN OIL(UNII: A2M91M918C)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(UNII: 9XZ8H6N6OH)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
STARCH, CORN(UNII: O8232NY3SJ)
STEARIC ACID(UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
Product Characteristics
Color YELLOW Score no score
Shape ROUND Size 6 mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55253-601-3030 in 1 BOTTLE Type 0: Not a Combination Product21/12/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA020646 12/21/2012 08/31/2017

PRINCIPAL DISPLAY PANEL

Tiagabine Hydrochloride Tablets 2 mg, 30s Label

PRINCIPAL DISPLAY PANEL

Tiagabine Hydrochloride Tablets 4 mg, 30s Label