BRILINTA

Product NDC
0186-0777
11-digit product format
001860777
Labeler code
0186
Product ID
0186-0777_5e8e6357-e223-4acf-870d-829e251fba6a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ticagrelor
Dosage form
TABLET
Route
ORAL
Labeler
AstraZeneca Pharmaceuticals LP
Application
NDA022433
Marketing category
NDA
Marketing start
2011-08-05
Substance
TICAGRELOR
Active strength
90 mg/1
Pharmacologic classes
Cytochrome P450 3A4 Inhibitors [MoA], Decreased Platelet Aggregation [PE], P-Glycoprotein Inhibitors [MoA], P2Y12 Platelet Inhibitor [EPC], P2Y12 Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
BRILINTA
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TICAGRELOR90 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiGLH0314RVC
Rxcui1116635, 1116639, 1666332, 1666334

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2b3fae0e-1168-2920-6fac-e67420589ce0Product name920260113
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0186-0777-08BRILINTA8 in 1 BOTTLETABLET855
0186-0777-18BRILINTA180 in 1 BOTTLETABLET18055
0186-0777-28BRILINTA14 in 1 BOTTLETABLET1455
0186-0777-39BRILINTA10 in 1 BOX, UNIT-DOSETABLET1055
0186-0777-39BRILINTA10 in 1 BLISTER PACKTABLET1055
0186-0777-60BRILINTA60 in 1 BOTTLETABLET6055

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0186-0777-28EA - Each0186-07773dd41657-735a-4995-b50c-ee81e22c7fb812013-10-17
0186-0777-39EA - Each0186-077773f49498-c8e3-4fdd-870e-39ae40910f8312012-07-24
0186-0777-60EA - Each0186-0777e2210fdf-4ea2-40ff-aae5-91634b39aeba12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TICAGRELORACTIVE INGREDIENTGLH0314RVCBRILINTA (TICAGRELOR) TABLET [ASTRAZENECA LP]23
TICAGRELORACTIVE MOIETYGLH0314RVCBRILINTA (TICAGRELOR) TABLET [ASTRAZENECA LP]23
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPBRILINTA (TICAGRELOR) TABLET [ASTRAZENECA LP]23
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675BRILINTA (TICAGRELOR) TABLET [ASTRAZENECA LP]23
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTBRILINTA (TICAGRELOR) TABLET [ASTRAZENECA LP]23
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357BRILINTA (TICAGRELOR) TABLET [ASTRAZENECA LP]23
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PBRILINTA (TICAGRELOR) TABLET [ASTRAZENECA LP]23
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOBRILINTA (TICAGRELOR) TABLET [ASTRAZENECA LP]23
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BRILINTA (TICAGRELOR) TABLET [ASTRAZENECA LP]23
MANNITOLINACTIVE INGREDIENT3OWL53L36ABRILINTA (TICAGRELOR) TABLET [ASTRAZENECA LP]23
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQBRILINTA (TICAGRELOR) TABLET [ASTRAZENECA LP]23
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2BRILINTA (TICAGRELOR) TABLET [ASTRAZENECA LP]23
TALCINACTIVE INGREDIENT7SEV7J4R1UBRILINTA (TICAGRELOR) TABLET [ASTRAZENECA LP]23
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBRILINTA (TICAGRELOR) TABLET [ASTRAZENECA LP]23
WATERINACTIVE INGREDIENT059QF0KO0RBRILINTA (TICAGRELOR) TABLET [ASTRAZENECA LP]23
TICAGRELORACTIVE INGREDIENTGLH0314RVCBRILINTA (TICAGRELOR) TABLET [CARDINAL HEALTH]2
TICAGRELORACTIVE MOIETYGLH0314RVCBRILINTA (TICAGRELOR) TABLET [CARDINAL HEALTH]2
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPBRILINTA (TICAGRELOR) TABLET [CARDINAL HEALTH]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTBRILINTA (TICAGRELOR) TABLET [CARDINAL HEALTH]2
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PBRILINTA (TICAGRELOR) TABLET [CARDINAL HEALTH]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOBRILINTA (TICAGRELOR) TABLET [CARDINAL HEALTH]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BRILINTA (TICAGRELOR) TABLET [CARDINAL HEALTH]2
MANNITOLINACTIVE INGREDIENT3OWL53L36ABRILINTA (TICAGRELOR) TABLET [CARDINAL HEALTH]2
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQBRILINTA (TICAGRELOR) TABLET [CARDINAL HEALTH]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2BRILINTA (TICAGRELOR) TABLET [CARDINAL HEALTH]2
TALCINACTIVE INGREDIENT7SEV7J4R1UBRILINTA (TICAGRELOR) TABLET [CARDINAL HEALTH]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBRILINTA (TICAGRELOR) TABLET [CARDINAL HEALTH]2
WATERINACTIVE INGREDIENT059QF0KO0RBRILINTA (TICAGRELOR) TABLET [CARDINAL HEALTH]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0186-0777BRILINTA (TICAGRELOR) TABLET [ASTRAZENECA PHARMACEUTICALS LP]53Current NDC, Legacy NDC, 6 package rows20241116_f7b3f443-e83d-4bf2-0e96-023448fed9a8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1666334BRILINTA (ticagrelor) 60 MG Oral TabletPSNf7b3f443-e83d-4bf2-0e96-023448fed9a855
1116639BRILINTA (ticagrelor) 90 MG Oral TabletPSNf7b3f443-e83d-4bf2-0e96-023448fed9a855
1666332ticagrelor 60 MG Oral TabletPSNf7b3f443-e83d-4bf2-0e96-023448fed9a855
1116635ticagrelor 90 MG Oral TabletPSNf7b3f443-e83d-4bf2-0e96-023448fed9a855
1666334ticagrelor 60 MG Oral Tablet [Brilinta]SBDf7b3f443-e83d-4bf2-0e96-023448fed9a855
1116639ticagrelor 90 MG Oral Tablet [Brilinta]SBDf7b3f443-e83d-4bf2-0e96-023448fed9a855
1666332ticagrelor 60 MG Oral TabletSCDf7b3f443-e83d-4bf2-0e96-023448fed9a855
1116635ticagrelor 90 MG Oral TabletSCDf7b3f443-e83d-4bf2-0e96-023448fed9a855
1666334Brilinta 60 MG Oral TabletSYf7b3f443-e83d-4bf2-0e96-023448fed9a855
1116639Brilinta 90 MG Oral TabletSYf7b3f443-e83d-4bf2-0e96-023448fed9a855
1116639BRILINTA (ticagrelor) 90 MG Oral TabletPSN4f9bd52a-99a7-4606-92b4-456a917aabef19
1116635ticagrelor 90 MG Oral TabletPSN4f9bd52a-99a7-4606-92b4-456a917aabef19
1116639ticagrelor 90 MG Oral Tablet [Brilinta]SBD4f9bd52a-99a7-4606-92b4-456a917aabef19
1116635ticagrelor 90 MG Oral TabletSCD4f9bd52a-99a7-4606-92b4-456a917aabef19
1116639Brilinta 90 MG Oral TabletSY4f9bd52a-99a7-4606-92b4-456a917aabef19
1116639BRILINTA (ticagrelor) 90 MG Oral TabletPSN1547e2b6-8858-178e-e063-6394a90abb232
1116635ticagrelor 90 MG Oral TabletPSN1547e2b6-8858-178e-e063-6394a90abb232
1116639ticagrelor 90 MG Oral Tablet [Brilinta]SBD1547e2b6-8858-178e-e063-6394a90abb232
1116635ticagrelor 90 MG Oral TabletSCD1547e2b6-8858-178e-e063-6394a90abb232
1116639Brilinta 90 MG Oral TabletSY1547e2b6-8858-178e-e063-6394a90abb232

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0186-0777-08001860777088 TABLET in 1 BOTTLE (0186-0777-08) 8 tablet2011-08-050000-00-00YesNoCurrent
0186-0777-1800186077718180 in 1 BOTTLEHistorical
0186-0777-280018607772814 in 1 BOTTLEHistorical
0186-0777-390018607773910 BLISTER PACK in 1 BOX, UNIT-DOSE (0186-0777-39) / 10 TABLET in 1 BLISTER PACK10 blister pack2011-08-050000-00-00NoNoCurrent
0186-0777-600018607776060 TABLET in 1 BOTTLE (0186-0777-60) 60 tablet2011-08-050000-00-00NoNoCurrent