MedPath

Dextrose

Approved
Approval ID

6d1199d2-4a7d-4e6c-9785-2688888377bc

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 13, 2011

Manufacturers
FDA

Physicians Total Care, Inc.

DUNS: 194123980

Products 1

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

Dextrose

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code54868-3089
Application NumberNDA019445
Product Classification
M
Marketing Category
C73594
G
Generic Name
Dextrose
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 13, 2011
FDA Product Classification

INGREDIENTS (4)

DEXTROSE MONOHYDRATEActive
Quantity: 25 g in 50 mL
Code: LX22YL083G
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT

MedPath

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

© 2025 MedPath, Inc. All rights reserved.

Dextrose - FDA Drug Approval Details