tranexamic acid
These highlights do not include all the information needed to use TRANEXAMIC ACID INJECTION safetly and effectively. See full prescribing information for TRANEXAMIC ACID INJECTION. TRANEXAMIC ACID injection, for intravenous useInitial U.S. Approval: 1986
Approved
Approval ID
8004da00-e3d1-4a77-88ec-ccbde822a803
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 4, 2023
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
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 Code50090-5072
Application NumberANDA212676
Product Classification
M
Marketing Category
C73584
G
Generic Name
Tranexamic Acid
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateSeptember 11, 2020
FDA Product Classification
INGREDIENTS (2)
TRANEXAMIC ACIDActive
Quantity: 100 mg in 1 mL
Code: 6T84R30KC1
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT