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
81916afc-f83a-4bba-a810-17393980e27e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 1, 2021
Manufacturers
FDA
American Regent, Inc.
DUNS: 002033710
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 Code0517-0960
Application NumberANDA201885
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS
Effective DateMarch 1, 2021
Generic Nametranexamic acid
INGREDIENTS (2)
TRANEXAMIC ACIDActive
Quantity: 100 mg in 1 mL
Code: 6T84R30KC1
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT