ETHACRYNATE SODIUM- ethacrynate sodium injection, powder, lyophilized, for solution 
Zydus Lifesciences Limited

----------

Ethacrynate Sodium for Injection, USP

INTRAVENOUS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 50 MG SINGLE DOSE VIAL CONTAINER LABEL

NDC 70771-1106-1

Ethacrynate Sodium for Injection, USP

50 mg/vial*

*50 mg Ethacrynic Acid Equivalent

For Intravenous Use

SINGLE DOSE VIAL

Rx only

Container Label

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 50 MG SINGLE DOSE VIAL CARTON LABEL

NDC 70771-1106-1

Ethacrynate Sodium for Injection, USP

50 mg/vial*

*50 mg Ethacrynic Acid Equivalent

For Intravenous Use

FOR THE PREPARATION OF INTRAVENOUS SOLUTIONS

ETHACRYNATE SODIUM (active ingredient)

SINGLE DOSE VIAL

Rx only

Carton Label
ETHACRYNATE SODIUM 
ethacrynate sodium injection, powder, lyophilized, for solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1106
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ETHACRYNATE SODIUM (UNII: K41MYV7MPM) (ETHACRYNIC ACID - UNII:M5DP350VZV) ETHACRYNIC ACID50 mg  in 50 mL
Inactive Ingredients
Ingredient NameStrength
MANNITOL (UNII: 3OWL53L36A) 62.5 mg  in 50 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1106-11 in 1 CARTON01/24/201803/25/2025
150 mL in 1 VIAL; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20775801/24/201806/03/2025
Labeler - Zydus Lifesciences Limited (918596198)
Registrant - Zydus Lifesciences Limited (918596198)

Revised: 6/2025
Document Id: 8036bc9b-bbb6-41f2-9128-12a1efa39e53
Set id: 2939538d-703d-40c3-8a08-83885a48a088
Version: 4
Effective Time: 20250603
 
Zydus Lifesciences Limited