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Acetazolamide

AcetaZOLAMIDE for Injection, USP For Intravenous Use Rx Only

Approved
Approval ID

a9199d3c-ce52-4db5-aa36-408f4e15e344

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 5, 2024

Manufacturers
FDA

XGen Pharmaceuticals DJB, Inc.

DUNS: 117380305

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Acetazolamide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code39822-0190
Application NumberANDA040784
Product Classification
M
Marketing Category
C73584
G
Generic Name
Acetazolamide
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 5, 2024
FDA Product Classification

INGREDIENTS (3)

HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
ACETAZOLAMIDE SODIUMActive
Quantity: 500 mg in 5 mL
Code: 429ZT169UH
Classification: ACTIM

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Acetazolamide - FDA Drug Approval Details