MedPath

Acetazolamide

AcetaZOLAMIDE for Injection USPFor Intravenous UseRx only

Approved
Approval ID

60f656ff-97b1-4a89-99af-8100483c2bac

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 13, 2023

Manufacturers
FDA

Heritage Pharmaceuticals Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.

DUNS: 780779901

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 Code23155-313
Application NumberANDA202693
Product Classification
M
Marketing Category
C73584
G
Generic Name
Acetazolamide
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 1, 2022
FDA Product Classification

INGREDIENTS (3)

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

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

Acetazolamide - FDA Drug Approval Details