Tranexamic Acid
These highlights do not include all the information needed to use tranexamic acid tablets safely and effectively. See full prescribing information for tranexamic acid tablets. TRANEXAMIC ACID tablets, for oral use Initial U.S. Approval: 1986
Approved
Approval ID
128c39ce-f625-47ec-9efe-4de696e5220f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 15, 2024
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Tranexamic Acid
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63629-8838
Application NumberANDA202093
Product Classification
M
Marketing Category
C73584
G
Generic Name
Tranexamic Acid
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 5, 2021
FDA Product Classification
INGREDIENTS (13)
TRANEXAMIC ACIDActive
Quantity: 650 mg in 1 1
Code: 6T84R30KC1
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
COPOVIDONE K25-31Inactive
Code: D9C330MD8B
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
GLYCERYL DIBEHENATEInactive
Code: R8WTH25YS2
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMERInactive
Code: 905HNO1SIH
Classification: IACT