FDA Product

Chlorothiazide

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Product Name

Chlorothiazide

FDA Product Code

63323-658

Regulatory Information

NDC Product Code

63323-658

Application Number

ANDA090896

Marketing Category

C73584

Effective Date

June 2, 2023

Territorial Authority

USA

FDA Title

Chlorothiazide Sodium for Injection, USP

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

4

Company Information

ManufacturerFresenius Kabi USA, LLC

DUNS Number

608775388

Active Ingredients

MANNITOL

Quantity: 250 mg in 18 mL

Code: 3OWL53L36A

Class Code: IACT

SODIUM HYDROXIDE

Code: 55X04QC32I

Class Code: IACT

CHLOROTHIAZIDE SODIUM

Quantity: 500 mg in 18 mL

Code: SN86FG7N2K

Class Code: ACTIM

Active Moieties

CHLOROTHIAZIDE

Code: 77W477J15H

© Copyright 2025. All Rights Reserved by MedPath

Home Terms & Conditions Privacy Policy