BRILINTA

Product NDC
71610-815
11-digit product format
716100815
Labeler code
71610
Product ID
71610-815_159d6ad1-edcf-d4da-e063-6294a90a6adb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ticagrelor
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
BRILINTA
Listing expiration
2026-12-31

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
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
71610-815-41BRILINTA5400 in 1 BOTTLETABLET54002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-815-41EA - Each71610-815b28bcd16-cc52-4f00-88ec-d7cb2542bf9e12024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-815BRILINTA (TICAGRELOR) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC ]2Current NDC, 1 package rows20240410_1547e2b6-8858-178e-e063-6394a90abb23.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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 startSampleExclude flagStatus
71610-815-41716100815415400 TABLET in 1 BOTTLE (71610-815-41) 5400 tablet2024-04-03NoNoHistorical