BRILINTA (Page 8 of 8)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 60 mg

NDC 0186-0776-60

60 tablets

BRILINTA®

ticagrelor tablets

60 mg

Rx only

Dispense the accompanying Medication Guide to each patient.

AstraZeneca

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 90 mg

NDC 0186-0777-60

60 tablets

BRILINTA®

ticagrelor tablets

90 mg

Rx only

Dispense the accompanying Medication Guide to each patient.

AstraZeneca

BRILINTA ticagrelor 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 (TICAGRELOR) TICAGRELOR 90 mg

Inactive Ingredients Ingredient Name Strength MANNITOL DIBASIC CALCIUM PHOSPHATE DIHYDRATE SODIUM STARCH GLYCOLATE TYPE A POTATO HYDROXYPROPYL CELLULOSE (1600000 WAMW) MAGNESIUM STEARATE WATER HYPROMELLOSE, UNSPECIFIED TITANIUM DIOXIDE TALC POLYETHYLENE GLYCOL 400 FERRIC OXIDE YELLOW

Product Characteristics Color YELLOW Score no score Shape ROUND (biconvex) Size 9mm Flavor Imprint Code 90;T Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0186-0777-08 8 TABLET in 1 BOTTLE None 2 NDC:0186-0777-60 60 TABLET in 1 BOTTLE None 3 NDC:0186-0777-18 180 TABLET in 1 BOTTLE None 4 NDC:0186-0777-39 10 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK 4 10 TABLET in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (0186-0777-39) 5 NDC:0186-0777-28 14 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA022433 08/05/2011

BRILINTA ticagrelor 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 (TICAGRELOR) TICAGRELOR 60 mg

Inactive Ingredients Ingredient Name Strength MANNITOL DIBASIC CALCIUM PHOSPHATE DIHYDRATE SODIUM STARCH GLYCOLATE TYPE A POTATO HYDROXYPROPYL CELLULOSE (1600000 WAMW) MAGNESIUM STEARATE WATER HYPROMELLOSE, UNSPECIFIED TITANIUM DIOXIDE TALC POLYETHYLENE GLYCOL 400 FERROSOFERRIC OXIDE FERRIC OXIDE RED

Product Characteristics Color PINK Score no score Shape ROUND (biconvex) Size 8mm Flavor Imprint Code 60;T Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0186-0776-60 60 TABLET in 1 BOTTLE None 2 NDC:0186-0776-94 1 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK 2 14 TABLET in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (0186-0776-94)

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)

Revised: 11/2020 AstraZeneca Pharmaceuticals LP