FDA.reportPublic FDA data

Ticagrelor

Product NDC
67877-522
11-digit product format
678770522
Labeler code
67877
Product ID
67877-522_0e2da4e0-7930-4f20-a63e-bd8b75cfb47d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ticagrelor
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Ascend Laboratories, LLC
Application
ANDA210219
Marketing category
ANDA
Marketing start
2025-10-28
Substance
TICAGRELOR
Active strength
60 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
TICAGRELOR60 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiGLH0314RVC
Rxcui1666332

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
67877-522-05Ticagrelor500 in 1 BOTTLETABLET, FILM COATED50010
67877-522-14Ticagrelor14 in 1 BOTTLETABLET, FILM COATED1410
67877-522-18Ticagrelor180 in 1 BOTTLETABLET, FILM COATED18010
67877-522-38Ticagrelor10 in 1 BLISTER PACKTABLET, FILM COATED1010
67877-522-38Ticagrelor10 in 1 CARTONTABLET, FILM COATED1010
67877-522-60Ticagrelor60 in 1 BOTTLETABLET, FILM COATED6010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-522-60EA - Each67877-522d0ecff83-17e0-4a21-bcf9-df9d99b6972f12025-11-13

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1666332ticagrelor 60 MG Oral TabletPSN3225098b-3138-4aec-a866-de94c3006e8e10
1666332ticagrelor 60 MG Oral TabletSCD3225098b-3138-4aec-a866-de94c3006e8e10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67877-522-0567877052205500 TABLET, FILM COATED in 1 BOTTLE (67877-522-05) 2025-10-28NoNoHistorical
67877-522-146787705221414 TABLET, FILM COATED in 1 BOTTLE (67877-522-14) 2025-10-28NoNoHistorical
67877-522-1867877052218180 TABLET, FILM COATED in 1 BOTTLE (67877-522-18) 2025-10-28NoNoHistorical
67877-522-386787705223810 BLISTER PACK in 1 CARTON (67877-522-38) / 10 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2025-10-28NoNoHistorical
67877-522-606787705226060 TABLET, FILM COATED in 1 BOTTLE (67877-522-60) 2025-10-28NoNoHistorical