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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 203451

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NDA 203451 describes DEXTROSE 50%, which is a drug marketed by Hospira, Intl Medication Sys, Baxter Hlthcare, Icu Medical Inc, and Otsuka Icu Medcl, and is included in six NDAs. It is available from eight suppliers. Additional details are available on the DEXTROSE 50% profile page.

The generic ingredient in DEXTROSE 50% is dextrose. There are nine drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the dextrose profile page.

Summary for 203451

Tradename:	DEXTROSE 50%
Applicant:	Intl Medication Sys
Ingredient:	dextrose
Patents:	0

Suppliers and Packaging for NDA: 203451

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DEXTROSE 50%	dextrose	INJECTABLE;INJECTION	203451	ANDA	HF Acquisition Co LLC, DBA HealthFirst	51662-1584	51662-1584-1	1 SYRINGE in 1 CARTON (51662-1584-1) / 50 mL in 1 SYRINGE
DEXTROSE 50%	dextrose	INJECTABLE;INJECTION	203451	ANDA	HF Acquisition Co LLC, DBA HealthFirst	51662-1584	51662-1584-3	10 POUCH in 1 CASE (51662-1584-3) / 1 SYRINGE in 1 POUCH (51662-1584-2) / 50 mL in 1 SYRINGE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	500MG/ML
Approval Date:	Mar 26, 2021	TE:	AP	RLD:	No

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