NORMOSOL-M AND DEXTROSE is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Icu Medical Inc.. The primary component is Dextrose Monohydrate; Sodium Chloride; Potassium Acetate; Magnesium Acetate.
| Product ID | 0990-7965_019a16e8-07c8-4dd3-a5ad-9101c9ea54a2 |
| NDC | 0990-7965 |
| Product Type | Human Prescription Drug |
| Proprietary Name | NORMOSOL-M AND DEXTROSE |
| Generic Name | Dextrose Monohydrate, Sodium Chloride, Potassium Acetate, And Magnesium Acetate |
| Dosage Form | Injection, Solution |
| Route of Administration | INTRAVENOUS |
| Marketing Start Date | 2021-02-08 |
| Marketing Category | NDA / NDA |
| Application Number | NDA017610 |
| Labeler Name | ICU Medical Inc. |
| Substance Name | DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; POTASSIUM ACETATE; MAGNESIUM ACETATE |
| Active Ingredient Strength | 5 g/100mL; mg/100mL; mg/100mL; mg/100mL |
| Pharm 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 | N |
| Listing Certified Through | 2022-12-31 |
| Marketing Start Date | 2021-02-08 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0409-7965 | Normosol-M and Dextrose | DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, POTASSIUM ACETATE, and MAGNESIUM ACETATE |
| 0990-7965 | NORMOSOL-M AND DEXTROSE | dextrose monohydrate, sodium chloride, potassium acetate, and magnesium acetate |