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 useInitial U.S. Approval: 1986
Approved
Approval ID
6f033f1e-8c78-4c87-b870-6493944315ff
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 11, 2021
Manufacturers
FDA
Mylan Institutional LLC
DUNS: 790384502
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 Code67457-197
Application NumberANDA091657
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS
Effective DateNovember 16, 2016
Generic Nametranexamic acid
INGREDIENTS (2)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TRANEXAMIC ACIDActive
Quantity: 100 mg in 1 mL
Code: 6T84R30KC1
Classification: ACTIB