Ticagrelor

Product NDC
71610-958
11-digit product format
716100958
Labeler code
71610
Product ID
71610-958_445e4a36-0326-75ec-e063-6294a90aaa26
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ticagrelor
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA208584
Marketing category
ANDA
Marketing start
2025-05-01
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
Ticagrelor
Listing expiration
2026-12-31

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
71610-958-41Ticagrelor5400 in 1 BOTTLETABLET54002
71610-958-42Ticagrelor1800 in 1 BOTTLETABLET18002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-958-41EA - Each71610-958b66da3bb-7156-47f4-a311-58089048904e12025-12-16
71610-958-42EA - Each71610-9589ec9bd00-aff8-497b-8a80-6c7ffc6571a112026-03-17

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1116635ticagrelor 90 MG Oral TabletPSN41c5d35c-91de-a8a4-e063-6394a90ac5ff2
1116635ticagrelor 90 MG Oral TabletSCD41c5d35c-91de-a8a4-e063-6394a90ac5ff2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71610-958-41716100958415400 TABLET in 1 BOTTLE (71610-958-41) 5400 tablet2025-10-22NoNoHistorical
71610-958-42716100958421800 TABLET in 1 BOTTLE (71610-958-42) 1800 tablet2025-11-21NoNoHistorical