TICAGRELOR

Product NDC
76282-550
11-digit product format
762820550
Labeler code
76282
Product ID
76282-550_62c87369-6ec3-4cd5-82c6-a81c752be6ca
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TICAGRELOR
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Exelan Pharmaceuticals, Inc
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
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, 1666332

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
76282-550-01TICAGRELOR100 in 1 BOTTLETABLET, FILM COATED1002
76282-550-05TICAGRELOR500 in 1 BOTTLETABLET, FILM COATED5002
76282-550-60TICAGRELOR60 in 1 BOTTLETABLET, FILM COATED602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76282-550-60EA - Each76282-55099d65252-1cef-4213-8a72-ed8ca723dffb12025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76282-550TICAGRELOR TABLET, FILM COATED [EXELAN PHARMACEUTICALS, INC]1Current NDC, 3 package rows20250507_eb8fb960-1f0e-40b1-9889-b02296bb3c37.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1666332ticagrelor 60 MG Oral TabletPSNeb8fb960-1f0e-40b1-9889-b02296bb3c372
1116635ticagrelor 90 MG Oral TabletPSN37b2d081-c17a-c126-e063-6394a90a57292
1116635ticagrelor 90 MG Oral TabletPSNeb8fb960-1f0e-40b1-9889-b02296bb3c372
1666332ticagrelor 60 MG Oral TabletSCDeb8fb960-1f0e-40b1-9889-b02296bb3c372
1116635ticagrelor 90 MG Oral TabletSCD37b2d081-c17a-c126-e063-6394a90a57292
1116635ticagrelor 90 MG Oral TabletSCDeb8fb960-1f0e-40b1-9889-b02296bb3c372

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
76282-550-0176282055001100 TABLET, FILM COATED in 1 BOTTLE (76282-550-01) 2025-05-07NoNoHistorical
76282-550-0576282055005500 TABLET, FILM COATED in 1 BOTTLE (76282-550-05) 2025-05-07NoNoHistorical
76282-550-607628205506060 TABLET, FILM COATED in 1 BOTTLE (76282-550-60) 2025-05-07NoNoHistorical