TRANEXAMIC ACID injection, solution

Tranexamic Acid by

Drug Labeling and Warnings

Tranexamic Acid by is a Prescription medication manufactured, distributed, or labeled by Emcure Pharmaceuticals Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INDICATIONS AND USAGE

Tranexamic acid injection, USP is indicated in patients with hemophilia for short-term use (2 to 8 days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 14593-318-01

Tranexamic Acid Injection, USP

1000 mg/10 mL

(100 mg/mL)

Intravenous Use Only

Rx only

10 mL Single-Dose Vial

INGREDIENTS AND APPEARANCE

TRANEXAMIC ACID 
tranexamic acid injection, solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 14593-318
Route of Administration	INTRAVENOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRANEXAMIC ACID (UNII: 6T84R30KC1) (TRANEXAMIC ACID - UNII:6T84R30KC1)	TRANEXAMIC ACID	1 g  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14593-318-01	10 in 1 CARTON	10/28/2024
1		10 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA203521	10/28/2024

Labeler - Emcure Pharmaceuticals Limited (916921919)

Registrant - Emcure Pharmaceuticals Limited (916921919)

Establishment
Name	Address	ID/FEI	Business Operations
Emcure Pharmaceuticals Limited		675467924	ANALYSIS(14593-318) , MANUFACTURE(14593-318) , PACK(14593-318) , LABEL(14593-318)