TRANEXAMIC ACID injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

TRANEXAMIC ACID (UNII: 6T84R30KC1) (TRANEXAMIC ACID - UNII:6T84R30KC1)

Available from:

Zydus Lifesciences Limited

INN (International Name):

TRANEXAMIC ACID

Composition:

TRANEXAMIC ACID 100 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Tranexamic acid Injection is indicated in patients with hemophilia for short-term use (two to eight days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction. Tranexamic acid Injection is contraindicated: - In patients with acquired defective color vision, since this prohibits measuring one endpoint that should be followed as a measure of toxicity (see WARNINGS). - In patients with subarachnoid hemorrhage. Anecdotal experience indicates that cerebral edema and cerebral infarction may be caused by tranexamic acid in such patients. - In patients with active intravascular clotting. - In patients with hypersensitivity to tranexamic acid or any of the ingredients.

Product summary:

Tranexamic acid Injection 100 mg/mL NDC 70771-1085-6 10 X 10 mL Single Dose Vials

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TRANEXAMIC ACID - TRANEXAMIC ACID INJECTION
ZYDUS LIFESCIENCES LIMITED
----------
TRANEXAMIC ACID INJECTION 100 MG/ML, 10 ML
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
CONTAINER LABEL
NDC 70771-1085-1
Tranexamic Acid Injection
1000 mg/10 mL
(100 mg/mL)
Solution for Intravenous Injection
Discard any remaining portion after single use.
10 mL Single-Dose Vial
Rx only
zydus pharmaceuticals
CARTON LABEL
NDC 70771-1085-6
Tranexamic Acid Injection
1000 mg/10 mL
(100 mg/mL)
Solution for Intravenous Injection
Discard any remaining portion after single use.
10 X 10 mL Single-Dose Vials
Rx only
zydus pharmaceuticals
TRANEXAMIC ACID
tranexamic acid injection
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:70771-1085
ROUTE OF ADMINISTRATION
INTRAVENOUS
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF
STRENGTH
STRENGTH
TRANEXAMIC ACID (UNII: 6T84R30KC1) (TRANEXAMIC ACID -
UNII:6T84R30KC1)
TRANEXAMIC ACID
100 mg in 1 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
WATER (UNII: 059QF0KO0R)
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:70771-
1085-6
10 in 1 CARTON
10/04/2017
Zydus Lifesciences Limited
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
ANDA205228
10/04/2017
LABELER -
Zydus Lifesciences Limited (918596198)
REGISTRANT -
Zydus Lifesciences Limited (918596198)
ESTABLISHMENT
NAME
ADDRESS
ID/FEI
BUSINESS OPERATIONS
Zydus Lifesciences Limited
918596198
ANALYSIS(70771-1085) , MANUFACTURE(70771-1085)
Revised: 11/2022