Tranexamic Acid
These highlights do not include all the information needed to use TRANEXAMIC ACID INJECTION safely and effectively. See full prescribing information for TRANEXAMIC ACID INJECTION. TRANEXAMIC ACID injection, for intravenous use Initial U.S. Approval: 1986
Approved
Approval ID
a4d95a17-9745-4780-b4dc-8683df8ca5bd
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 27, 2021
Manufacturers
FDA
Amneal Pharmaceuticals LLC
DUNS: 827748190
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
NDC Product Code70121-1398
Application NumberANDA208840
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS
Effective DateFebruary 27, 2021
Generic NameTranexamic Acid
INGREDIENTS (2)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TRANEXAMIC ACIDActive
Quantity: 100 mg in 1 mL
Code: 6T84R30KC1
Classification: ACTIB