BRILINTA

Product NDC
0186-0776
11-digit product format
001860776
Labeler code
0186
Product ID
0186-0776_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
2015-09-04
Substance
TICAGRELOR
Active strength
60 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
TICAGRELOR60 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0186-0776-60BRILINTA60 in 1 BOTTLETABLET6055
0186-0776-94BRILINTA1 in 1 BOX, UNIT-DOSETABLET155
0186-0776-94BRILINTA14 in 1 BLISTER PACKTABLET1455

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0186-0776-60EA - Each0186-077626964b4f-f82a-4c60-8322-20800fce253d12015-10-02

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0186-0776BRILINTA (TICAGRELOR) TABLET [ASTRAZENECA PHARMACEUTICALS LP]53Current NDC, Legacy NDC, 3 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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0186-0776-600018607766060 TABLET in 1 BOTTLE (0186-0776-60) 60 tablet2015-09-040000-00-00NoNoCurrent
0186-0776-94001860776941 BLISTER PACK in 1 BOX, UNIT-DOSE (0186-0776-94) > 14 TABLET in 1 BLISTER PACK1 blister pack2015-09-040000-00-00YesNoCurrent