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

60_mg_tablets
(click image for full-size original)

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

90_mg_tablets
(click image for full-size original)
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: 09/2020 AstraZeneca Pharmaceuticals LP

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