Normosol-R and Dextrose

Product NDC

0409-7968

11-digit product format

004097968

Labeler code

0409

Product ID

0409-7968_aee1e595-1f94-4a1f-8bc6-a3d170493d06

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Dextrose, Sodium Chloride, Sodium Acetate Anhydrous, Sodium Gluconate, Potassium Chloride, and Magnesium Chloride

Dosage form

INJECTION, SOLUTION

Route

INTRAVENOUS

Labeler

Hospira, Inc.

Application

NDA017609

Marketing category

NDA

Marketing start

2010-09-16

Marketing end

2020-09-01

Substance

DEXTROSE, UNSPECIFIED FORM; SODIUM CHLORIDE; SODIUM ACETATE ANHYDROUS; SODIUM GLUCONATE; POTASSIUM CHLORIDE; MAGNESIUM CHLORIDE

Active strength

5 g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL

Pharmacologic classes

Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [CS],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record