Isolyte P in Dextrose is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by B. Braun Medical Inc.. The primary component is Dextrose Monohydrate; Sodium Acetate; Potassium Chloride; Magnesium Chloride; Potassium Phosphate, Dibasic.
| Product ID | 0264-7730_451ceb0a-c083-4f3d-9c6e-87f10513211c |
| NDC | 0264-7730 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Isolyte P in Dextrose |
| Generic Name | Dextrose, Sodium Acetate, Potassium Chloride, Magnesium Chloride, And Potassium Phosphate, Dibasic |
| Dosage Form | Injection, Solution |
| Route of Administration | INTRAVENOUS |
| Marketing Start Date | 1993-06-10 |
| Marketing Category | NDA / NDA |
| Application Number | NDA019873 |
| Labeler Name | B. Braun Medical Inc. |
| Substance Name | DEXTROSE MONOHYDRATE; SODIUM ACETATE; POTASSIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC |
| Active Ingredient Strength | 5 g/100mL; g/100mL; g/100mL; g/100mL; g/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] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2019-12-31 |
| Marketing Start Date | 1993-06-10 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | NDA |
| Application Number | NDA019873 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 1993-06-10 |
| Marketing Category | NDA |
| Application Number | NDA019873 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 1993-06-10 |
| Marketing End Date | 2011-02-28 |
| Ingredient | Strength |
|---|---|
| DEXTROSE MONOHYDRATE | 5 g/100mL |
| SPL SET ID: | 4ea4397c-2fa4-4670-91e6-21ae498c88f7 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |