Ionosol MB 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 Lactate; Potassium Chloride; Magnesium Chloride; Monobasic Potassium Phosphate; Sodium Phosphate, Monobasic, Monohydrate.
| Product ID | 0990-7372_141f724f-c654-4793-998c-2d1e18e74e25 |
| NDC | 0990-7372 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Ionosol MB and Dextrose |
| Generic Name | Dextrose Monohydrate, Sodium Lactate, Potassium Chloride, Magnesium Chloride, Potassium Phosphate, Monobasic, And Sodium Phosphate, Monobasic, Monohydrate |
| Dosage Form | Injection, Solution |
| Route of Administration | INTRAVENOUS |
| Marketing Start Date | 2019-07-01 |
| Marketing Category | NDA / NDA |
| Application Number | NDA019513 |
| Labeler Name | ICU Medical Inc. |
| Substance Name | DEXTROSE MONOHYDRATE; SODIUM LACTATE; POTASSIUM CHLORIDE; MAGNESIUM CHLORIDE; MONOBASIC POTASSIUM PHOSPHATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE |
| 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],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],Potassium Compounds [CS],Potassium Salt [EPC],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] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2022-12-31 |
| Marketing Start Date | 2020-01-01 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | NDA |
| Application Number | NDA019513 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2020-01-01 |
| Marketing Category | NDA |
| Application Number | NDA019513 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2019-07-01 |
| Ingredient | Strength |
|---|---|
| DEXTROSE MONOHYDRATE | 5 g/100mL |
| SPL SET ID: | 1b457b1d-0e80-4578-ba6f-dedf513fc962 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0409-7372 | Ionosol MB and Dextrose | DEXTROSE MONOHYDRATE, SODIUM LACTATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, POTASSIUM PHOSPHATE, MONOBASIC, and SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE |
| 0990-7372 | Ionosol MB and Dextrose | DEXTROSE MONOHYDRATE, SODIUM LACTATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, POTASSIUM PHOSPHATE, MONOBASIC, and SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE |