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
d68b79ab-3104-410e-a63f-9919a23625af
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 7, 2025
Manufacturers
FDA
Alembic Pharmaceuticals Inc.
DUNS: 079288842
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 Code62332-241
Application NumberANDA208576
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ticagrelor
Product Specifications
Route of AdministrationORAL
Effective DateMay 7, 2025
FDA Product Classification
INGREDIENTS (11)
TICAGRELORActive
Quantity: 90 mg in 1 1
Code: GLH0314RVC
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT