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Dextrose

5% Dextrose Injection USP

Approved
Approval ID

60b6d7c3-0164-46c9-aa38-b5aa1c31a5d5

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 5, 2024

Manufacturers
FDA

B. Braun Medical Inc.

DUNS: 002397347

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 Code0264-1510
Application NumberNDA016730
Product Classification
M
Marketing Category
C73594
G
Generic Name
Dextrose
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 19, 2022
FDA Product Classification

INGREDIENTS (2)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
DEXTROSE MONOHYDRATEActive
Quantity: 50 mg in 1 mL
Code: LX22YL083G
Classification: ACTIB

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Dextrose - FDA Drug Approval Details