Ticagrelor

Product NDC
46708-500
11-digit product format
467080500
Labeler code
46708
Product ID
46708-500_ef3c94fb-69c7-4649-874d-bb4bedc1152d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ticagrelor
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Alembic Pharmaceuticals Limited
Application
ANDA208576
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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
GLH0314RVCTICAGRELOR274693-27-5TICAGRELOR

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
46708-500-604670805006060 TABLET, FILM COATED in 1 BOTTLE (46708-500-60) 2025-10-28NoNoHistorical
46708-500-7146708050071500 TABLET, FILM COATED in 1 BOTTLE (46708-500-71) 2025-10-28NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
TicagrelorAlembic Pharmaceuticals Limited2025-10-30Human Prescription Drug Label2
TicagrelorAlembic Pharmaceuticals Limited2025-05-05Human Prescription Drug Label1