Ticagrelor
These highlights do not include all the information needed to use TICAGRELOR TABLETS safely and effectively. See full prescribing information for TICAGRELOR TABLETS. TICAGRELOR tablets, for oral use Initial U.S. Approval: 2011
Approved
Approval ID
1225fd45-9b56-1671-ee77-cd0c9f2174a5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 13, 2024
Manufacturers
FDA
Dr. Reddys Laboratories Inc
DUNS: 802315887
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ticagrelor
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43598-480
Application NumberANDA208541
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ticagrelor
Product Specifications
Route of AdministrationORAL
Effective DateNovember 13, 2024
FDA Product Classification
INGREDIENTS (10)
TICAGRELORActive
Quantity: 90 mg in 1 1
Code: GLH0314RVC
Classification: ACTIB
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A CORNInactive
Code: AG9B65PV6B
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT