Acetazolamide (Page 3 of 3)

HOW SUPPLIED

Acetazolamide for injection, USP (lyophilized) powder is supplied as follows:

NDC	Strength	Package Factor
67457-853-50	500 mg/vial	1 vial per carton

Store drug product at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Store reconstituted solution in a refrigerator between 2° and 8°C (36° and 46°F).

Use within 12 hours of reconstitution. Discard unused portion.

Sterile, Nonpyrogenic, Preservative-free.

The container closure is not made with natural rubber latex.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Manufactured for:

Mylan Institutional LLC

Morgantown, WV 26505 U.S.A.

Manufactured by:

Mylan Laboratories Limited

Bangalore, India

AUGUST 2022

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

NDC 67457-853-50

AcetaZOLAMIDE for Injection, USP

500 mg*

For Intravenous Use

Sterile

Mylan

Rx only

One Vial

ACETAZOLAMIDE acetazolamide sodium injection, powder, lyophilized, for solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67457-853 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength acetazolamide sodium (acetazolamide) acetazolamide 500 mg in 5 mL

Inactive Ingredients Ingredient Name Strength sodium hydroxide hydrochloric acid

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:67457-853-50 1 VIAL in 1 CARTON contains a VIAL 1 5 mL in 1 VIAL This package is contained within the CARTON (67457-853-50)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA200880 09/13/2018

Labeler — Mylan Institutional LLC (790384502)

Revised: 08/2022 Mylan Institutional LLC