MedPath

Dextrose Monohydrate

50 % Dextrose Injection, USP

Approved
Approval ID

3a9d9c4a-5e4e-4bb6-b2a9-55e1b0b98f02

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 28, 2016

Manufacturers
FDA

International Medication Systems, Limited

DUNS: 055750020

Products 1

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

Dextrose Monohydrate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code76329-3301
Product Classification
G
Generic Name
Dextrose Monohydrate
Product Specifications
Route of AdministrationPARENTERAL
Effective DateNovember 18, 2016
FDA Product Classification

INGREDIENTS (2)

WaterInactive
Code: 059QF0KO0R
Classification: IACT
DEXTROSE MONOHYDRATEActive
Quantity: 500 mg in 1 mL
Code: LX22YL083G
Classification: ACTIB

MedPath

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

© 2025 MedPath, Inc. All rights reserved.

Dextrose Monohydrate - FDA Drug Approval Details