FDA.reportPublic FDA data

Ticagrelor

Product NDC
67877-491
11-digit product format
678770491
Labeler code
67877
Product ID
67877-491_d7f89cc8-6226-4caa-b8ee-22155683489c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ticagrelor
Dosage form
TABLET
Route
ORAL
Labeler
Ascend Laboratories, LLC
Application
ANDA208567
Marketing category
ANDA
Marketing start
2025-04-30
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
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
67877-491-05Ticagrelor500 in 1 BOTTLETABLET50019
67877-491-60Ticagrelor60 in 1 BOTTLETABLET6019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-491-05EA - Each67877-4913e01061c-5523-4472-b52f-0260a387b8dd12026-04-20
67877-491-60EA - Each67877-491e1b480cc-739d-43a3-8420-42ea40a4421312025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-491TICAGRELOR TABLET [ASCEND LABORATORIES, LLC]16Current NDC, 2 package rows20250430_2f73a4db-2c7f-4e42-a914-87aedc2780fb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1116635ticagrelor 90 MG Oral TabletPSN2f73a4db-2c7f-4e42-a914-87aedc2780fb19
1116635ticagrelor 90 MG Oral TabletSCD2f73a4db-2c7f-4e42-a914-87aedc2780fb19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67877-491-0567877049105500 TABLET in 1 BOTTLE (67877-491-05) 500 tablet2026-03-05NoNoHistorical
67877-491-606787704916060 TABLET in 1 BOTTLE (67877-491-60) 60 tablet2025-04-30NoNoHistorical