Details for New Drug Application (NDA): 017484

NDA 017484 describes DEXTROSE 5% AND ELECTROLYTE NO. 48 IN PLASTIC CONTAINER, which is a drug marketed by Baxter Hlthcare and is included in one NDA. It is available from one supplier. Additional details are available on the DEXTROSE 5% AND ELECTROLYTE NO. 48 IN PLASTIC CONTAINER profile page.

The generic ingredient in DEXTROSE 5% AND ELECTROLYTE NO. 48 IN PLASTIC CONTAINER is dextrose; magnesium chloride; potassium chloride; potassium phosphate, monobasic; sodium chloride; sodium lactate. There are nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the dextrose; magnesium chloride; potassium chloride; potassium phosphate, monobasic; sodium chloride; sodium lactate profile page.

Summary for 017484

Tradename:	DEXTROSE 5% AND ELECTROLYTE NO. 48 IN PLASTIC CONTAINER
Applicant:	Baxter Hlthcare
Ingredient:	dextrose; magnesium chloride; potassium chloride; potassium phosphate, monobasic; sodium chloride; sodium lactate
Patents:	0

Pharmacology for NDA: 017484

Mechanism of Action	Acidifying Activity Osmotic Activity
Physiological Effect	Increased Large Intestinal Motility Inhibition Large Intestine Fluid/Electrolyte Absorption

Suppliers and Packaging for NDA: 017484

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DEXTROSE 5% AND ELECTROLYTE NO. 48 IN PLASTIC CONTAINER	dextrose; magnesium chloride; potassium chloride; potassium phosphate, monobasic; sodium chloride; sodium lactate	INJECTABLE;INJECTION	017484	NDA	Baxter Healthcare Corporation	0338-0143	0338-0143-03	500 mL in 1 BAG (0338-0143-03)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	5GM/100ML;31MG/100ML;141MG/100ML;20MG/100ML;12MG/100ML;260MG/100ML
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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