Normosol-R 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, Unspecified Form; Sodium Chloride; Sodium Acetate Anhydrous; Sodium Gluconate; Potassium Chloride; Magnesium Chloride.
| Product ID | 0990-7968_603465f1-e106-4247-b1f2-8171dffac0a6 |
| NDC | 0990-7968 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Normosol-R and Dextrose |
| Generic Name | Dextrose, Sodium Chloride, Sodium Acetate Anhydrous, Sodium Gluconate, Potassium Chloride, And Magnesium Chloride |
| Dosage Form | Injection, Solution |
| Route of Administration | INTRAVENOUS |
| Marketing Start Date | 2020-05-14 |
| Marketing Category | NDA / NDA |
| Application Number | NDA017609 |
| Labeler Name | ICU Medical Inc. |
| Substance Name | DEXTROSE, UNSPECIFIED FORM; SODIUM CHLORIDE; SODIUM ACETATE ANHYDROUS; SODIUM GLUCONATE; POTASSIUM CHLORIDE; MAGNESIUM CHLORIDE |
| Active Ingredient Strength | 5 g/100mL; mg/100mL; mg/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],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 | N |
| Listing Certified Through | 2022-12-31 |
| Marketing Start Date | 2020-05-14 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | NDA |
| Application Number | NDA017609 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2020-05-14 |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0409-7968 | Normosol-R and Dextrose | Dextrose, Sodium Chloride, Sodium Acetate Anhydrous, Sodium Gluconate, Potassium Chloride, and Magnesium Chloride |
| 0990-7968 | Normosol-R and Dextrose | Dextrose, Sodium Chloride, Sodium Acetate Anhydrous, Sodium Gluconate, Potassium Chloride, and Magnesium Chloride |