ACETAZOLAMIDE - acetazolamide injection, powder, lyophilized, for solution 
Zydus Lifesciences Limited

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AcetaZOLAMIDE for Injection USP For Intravenous Use.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Container Label

NDC 70771-1490-1

AcetaZOLAMIDE for Injection USP

500 mg* per vial

For Intravenous Use

1 Single-Dose Vial

Rx Only

figure02

Carton Label

NDC 70771-1490-1

AcetaZOLAMIDE for Injection USP

500 mg* per vial

For Intravenous Use

1 Single-Dose Vial

Rx Only

figure03
ACETAZOLAMIDE 
acetazolamide injection, powder, lyophilized, for solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1490
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAZOLAMIDE SODIUM (UNII: 429ZT169UH) (ACETAZOLAMIDE - UNII:O3FX965V0I) ACETAZOLAMIDE500 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1490-11 in 1 CARTON01/09/2020
15 mL in 1 VIAL; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20653301/09/2020
Labeler - Zydus Lifesciences Limited (918596198)
Registrant - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited918596198ANALYSIS(70771-1490) , MANUFACTURE(70771-1490)

Revised: 10/2022
Document Id: 7cb9ae99-0542-483d-b7b2-8eef7154bcd5
Set id: 1269804e-7d32-466c-83e7-99e6ddceb8b2
Version: 3
Effective Time: 20221017
 
Zydus Lifesciences Limited