Normosol-M and Dextrose

Product NDC

0409-7965

11-digit product format

004097965

Labeler code

0409

Product ID

0409-7965_86cb991a-eca9-4aa2-a93d-6a11e64b709d

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, POTASSIUM ACETATE, and MAGNESIUM ACETATE

Dosage form

INJECTION, SOLUTION

Route

INTRAVENOUS

Labeler

Hospira, Inc.

Application

NDA017610

Marketing category

NDA

Marketing start

1975-08-13

Marketing end

2021-05-01

Substance

DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; POTASSIUM ACETATE; MAGNESIUM ACETATE

Active strength

5 g/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],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