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
3bb850aa-2061-4c30-848a-82871ff7bbf5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 18, 2023
Manufacturers
FDA
Methapharm, Inc.
DUNS: 066672887
Products 2
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 Code67850-042
Application NumberANDA202436
Product Classification
M
Marketing Category
C73584
G
Generic Name
Tranexamic Acid
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateFebruary 25, 2021
FDA Product Classification
INGREDIENTS (2)
TRANEXAMIC ACIDActive
Quantity: 100 mg in 1 mL
Code: 6T84R30KC1
Classification: ACTIB
waterInactive
Code: 059QF0KO0R
Classification: IACT
Tranexamic Acid
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67850-041
Application NumberANDA202436
Product Classification
M
Marketing Category
C73584
G
Generic Name
Tranexamic Acid
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateFebruary 25, 2021
FDA Product Classification
INGREDIENTS (2)
TRANEXAMIC ACIDActive
Quantity: 100 mg in 1 mL
Code: 6T84R30KC1
Classification: ACTIB
waterInactive
Code: 059QF0KO0R
Classification: IACT