Tranexamic Acid

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

Company

DUNS: 845263701

Effective Date

December 5, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Tranexamic acid(100 mg in 1 mL)

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

DUNS Number

209429182

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

NDC Product Code

60505-6169

Application Number

ANDA209860

Marketing Category

ANDA (C73584)

Route of Administration

INTRAVENOUS

Effective Date

December 5, 2023

Ingredients

Code: 6T84R30KC1Class: ACTIBQuantity: 100 mg in 1 mL

WATERInactive

Code: 059QF0KO0RClass: IACT