Acetazolamide (Page 3 of 3)


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



Package Factor


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



NDC 67457-853-50

AcetaZOLAMIDE for Injection, USP

500 mg*

For Intravenous Use



Rx only

One Vial

(click image for full-size original)
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
# 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

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