Normosol-R is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Hospira, Inc.. The primary component is Sodium Chloride; Sodium Acetate Anhydrous; Sodium Gluconate; Potassium Chloride; Magnesium Chloride.
| Product ID | 0409-7967_71d7ed68-b1a6-4d4e-b8f4-56ceee199afe |
| NDC | 0409-7967 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Normosol-R |
| Generic Name | Sodium Chloride, Sodium Acetate Anhydrous, Sodium Gluconate, Potassium Chloride, And Magnesium Chloride |
| Dosage Form | Injection, Solution |
| Route of Administration | INTRAVENOUS |
| Marketing Start Date | 2010-09-20 |
| Marketing Category | NDA / NDA |
| Application Number | NDA017586 |
| Labeler Name | Hospira, Inc. |
| Substance Name | SODIUM CHLORIDE; SODIUM ACETATE ANHYDROUS; SODIUM GLUCONATE; POTASSIUM CHLORIDE; MAGNESIUM CHLORIDE |
| Active Ingredient Strength | 526 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 | 2020-12-31 |
| Marketing Start Date | 2010-09-20 |
| Marketing End Date | 2022-07-08 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | NDA |
| Application Number | NDA017586 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2010-09-20 |
| Marketing Category | NDA |
| Application Number | NDA017586 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2010-09-20 |
| Marketing Category | NDA |
| Application Number | NDA017586 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2011-03-22 |
| Marketing End Date | 2011-03-23 |
| Ingredient | Strength |
|---|---|
| SODIUM CHLORIDE | 526 mg/100mL |
| SPL SET ID: | c3335a21-20c9-46a5-5d9f-12227d67fd11 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0409-7670 | Normosol-R | SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE |
| 0409-7967 | Normosol-R | SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE |
| 0990-7670 | Normosol-R | SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE |
| 0990-7967 | Normosol-R | SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE |
| 0409-6141 | Physiosol | SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, and MAGNESIUM CHLORIDE |
| 0990-6141 | Physiosol | SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, and MAGNESIUM CHLORIDE |