TRANEXAMIC ACID - tranexamic acid injection 
Zydus Lifesciences Limited

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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

figure02

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

figure03
TRANEXAMIC ACID 
tranexamic acid injection
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1085
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRANEXAMIC ACID (UNII: 6T84R30KC1) (TRANEXAMIC ACID - UNII:6T84R30KC1) TRANEXAMIC ACID100 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1085-610 in 1 CARTON10/04/2017
110 mL in 1 VIAL; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20522810/04/2017
Labeler - Zydus Lifesciences Limited (918596198)
Registrant - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited918596198ANALYSIS(70771-1085) , MANUFACTURE(70771-1085)

Revised: 11/2022
Document Id: a570790b-00e9-493b-9605-3839d213d772
Set id: 572b90ba-4a04-466c-bf6b-49a0d7c6b5d4
Version: 5
Effective Time: 20221105
 
Zydus Lifesciences Limited