BRILINTA

Product NDC
55154-9618
11-digit product format
551549618
Labeler code
55154
Product ID
55154-9618_81bf7599-8e7c-4e30-a7aa-63ea3040daef
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ticagrelor
Dosage form
TABLET
Route
ORAL
Labeler
Cardinal Health 107, LLC
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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2b3fae0e-1168-2920-6fac-e67420589ce0Product name920260113
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
55154-9618-0BRILINTA1 in 1 BLISTER PACKTABLET119
55154-9618-0BRILINTA10 in 1 BAGTABLET1019
55154-9618-8BRILINTA1440 in 1 BOTTLE, PLASTICTABLET144019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55154-9618-0EA - Each55154-96188c7f0404-c279-4766-bed3-30891401980012022-04-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
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
55154-9618BRILINTA (TICAGRELOR) TABLET [CARDINAL HEALTH 107, LLC]15Current NDC, Legacy NDC, 3 package rows20240901_4f9bd52a-99a7-4606-92b4-456a917aabef.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55154-9618-05515496180010 BLISTER PACK in 1 BAG (55154-9618-0) / 1 TABLET in 1 BLISTER PACK10 blister pack2011-08-050000-00-00NoNoCurrent
55154-9618-8551549618081440 TABLET in 1 BOTTLE, PLASTIC (55154-9618-8) 1440 tablet2011-08-052027-09-30NoNoCurrent