NDC Code(s) : 0186-0777-08, 0186-0777-60, 0186-0777-18, 0186-0777-39, 0186-0777-28, 0186-0776-60, 0186-0776-94
Packager : AstraZeneca Pharmaceuticals LP

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

BRILINTATicagrelor TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0186-0777
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TICAGRELOR(UNII: GLH0314RVC)
(TICAGRELOR - UNII:GLH0314RVC) 		TICAGRELOR90 mg
Inactive Ingredients
Ingredient Name Strength
MANNITOL(UNII: 3OWL53L36A)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE(UNII: O7TSZ97GEP)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(UNII: RFW2ET671P)
MAGNESIUM STEARATE(UNII: 70097M6I30)
WATER(UNII: 059QF0KO0R)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TALC(UNII: 7SEV7J4R1U)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
Product Characteristics
Color YELLOW Score no score
Shape ROUND (biconvex) Size 9 mm
Flavor Imprint Code 90;T
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0186-0777-088 in 1 BOTTLE Type 0: Not a Combination Product08/05/2011
2NDC:0186-0777-6060 in 1 BOTTLE Type 0: Not a Combination Product08/05/2011
3NDC:0186-0777-18180 in 1 BOTTLE Type 0: Not a Combination Product08/05/2011
4NDC:0186-0777-3910 in 1 BOX, UNIT-DOSE 08/05/2011
410 in 1 BLISTER PACK Type 0: Not a Combination Product08/05/2011
5NDC:0186-0777-2814 in 1 BOTTLE Type 0: Not a Combination Product08/05/2011
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022433 08/05/2011
BRILINTATicagrelor TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0186-0776
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TICAGRELOR(UNII: GLH0314RVC)
(TICAGRELOR - UNII:GLH0314RVC) 		TICAGRELOR60 mg
Inactive Ingredients
Ingredient Name Strength
MANNITOL(UNII: 3OWL53L36A)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE(UNII: O7TSZ97GEP)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(UNII: RFW2ET671P)
MAGNESIUM STEARATE(UNII: 70097M6I30)
WATER(UNII: 059QF0KO0R)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TALC(UNII: 7SEV7J4R1U)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
FERRIC OXIDE RED(UNII: 1K09F3G675)
Product Characteristics
Color PINK Score no score
Shape ROUND (biconvex) Size 8 mm
Flavor Imprint Code 60;T
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0186-0776-6060 in 1 BOTTLE Type 0: Not a Combination Product09/04/2015
2NDC:0186-0776-941 in 1 BOX, UNIT-DOSE 09/04/2015
214 in 1 BLISTER PACK Type 0: Not a Combination Product09/04/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022433 09/04/2015

LABELER - AstraZeneca Pharmaceuticals LP(938368834)

REGISTRANT - AstraZeneca PLC(230790719)

PRINCIPAL DISPLAY PANEL

NDC 0186-0776-60

60 tablets

BRILINTA®

ticagrelor tablets

60 mg

Rx only

Dispense the accompanying Medication Guide to each patient.

AstraZeneca

60_mg_label

PRINCIPAL DISPLAY PANEL

NDC 0186-0777-60

60 tablets

BRILINTA®

ticagrelor tablets

90 mg

Rx only

Dispense the accompanying Medication Guide to each patient.

AstraZeneca

90_mg_label