TICAGRELOR

Product NDC
71610-914
11-digit product format
716100914
Labeler code
71610
Product ID
71610-914_4887c1b7-be57-6eb9-e063-6294a90ab88d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TICAGRELOR
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA208537
Marketing category
ANDA
Marketing start
2025-05-07
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
TICAGRELOR
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TICAGRELOR90 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiGLH0314RVC
Rxcui1116635

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
71610-914-41TICAGRELOR5400 in 1 BOTTLETABLET, FILM COATED54002
71610-914-42TICAGRELOR1800 in 1 BOTTLETABLET, FILM COATED18002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-914-41EA - Each71610-9147e2e9a0f-66fe-4398-875a-b83d33022c4c12025-07-08
71610-914-42EA - Each71610-9140ff148ac-babe-46c1-ab85-2d36a0d7eade12026-03-17

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1116635ticagrelor 90 MG Oral TabletPSN37b2d081-c17a-c126-e063-6394a90a57292
1116635ticagrelor 90 MG Oral TabletSCD37b2d081-c17a-c126-e063-6394a90a57292

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71610-914-41716100914415400 TABLET, FILM COATED in 1 BOTTLE (71610-914-41) 2025-06-13NoNoHistorical
71610-914-42716100914421800 TABLET, FILM COATED in 1 BOTTLE (71610-914-42) 2026-01-16NoNoHistorical