NDC 55792-007
Elliotts B
Sodium Cation, Sodium Bicarbonate, Anhydrous Dextrose, Magnesium Sulfate, Potassium Chloride, Calcium Chloride, Sodium Phosphate
Elliotts B is a Intrathecal Injection in the Human Prescription Drug category. It is labeled and distributed by Lukare Medical, Llc. The primary component is Sodium Chloride; Sodium Bicarbonate; Anhydrous Dextrose; Magnesium Sulfate, Unspecified; Potassium Chloride; Calcium Chloride; Sodium Phosphate.
| Product ID | 55792-007_1906f1b3-9423-4a47-b417-ffe3f075535e |
| NDC | 55792-007 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Elliotts B |
| Generic Name | Sodium Cation, Sodium Bicarbonate, Anhydrous Dextrose, Magnesium Sulfate, Potassium Chloride, Calcium Chloride, Sodium Phosphate |
| Dosage Form | Injection |
| Route of Administration | INTRATHECAL |
| Marketing Start Date | 2013-06-04 |
| Marketing Category | NDA / NDA |
| Application Number | NDA020577 |
| Labeler Name | Lukare Medical, LLC |
| Substance Name | SODIUM CHLORIDE; SODIUM BICARBONATE; ANHYDROUS DEXTROSE; MAGNESIUM SULFATE, UNSPECIFIED; POTASSIUM CHLORIDE; CALCIUM CHLORIDE; SODIUM PHOSPHATE |
| Active Ingredient Strength | 73 mg/10mL; mg/10mL; mg/10mL; mg/10mL; mg/10mL; mg/10mL; mg/10mL |
| Pharm Classes | 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],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [CS],Cations, Divalent [CS] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
Packaging
NDC 55792-007-10
10 AMPULE in 1 BOX (55792-007-10) > 10 mL in 1 AMPULE (55792-007-01)
| Marketing Start Date | 2013-06-04 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 55792-007-01 [55792000701]
Elliotts B INJECTION
| Marketing Category | NDA |
| Application Number | NDA020577 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2013-06-04 |
NDC 55792-007-10 [55792000710]
Elliotts B INJECTION
| Marketing Category | NDA |
| Application Number | NDA020577 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2013-06-04 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| SODIUM CHLORIDE | 73 mg/10mL |
OpenFDA Data
| SPL SET ID: | 08036dbd-55b3-47b9-9890-000f253544f3 |
| Manufacturer | |
| UNII |
Pharmacological Class
- 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]
- Blood Coagulation Factor [EPC]
- Increased Coagulation Factor Activity [PE]
- Calcium [CS]
- Cations
- Divalent [CS]
- 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]
- Blood Coagulation Factor [EPC]
- Increased Coagulation Factor Activity [PE]
- Calcium [CS]
- Cations
- Divalent [CS]
NDC Crossover Matching brand name "Elliotts B" or generic name "Sodium Cation, Sodium Bicarbonate, Anhydrous Dextrose, Magnesium Sulfate, Potassium Chloride, Calcium Chloride, Sodium Phosphate"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 55792-007 | Elliotts B | sodium cation, sodium bicarbonate, anhydrous dextrose, magnesium sulfate, potassium chloride, calcium chloride, sodium phosphate |
| 67871-007 | Elliotts B | sodium cation, sodium bicarbonate, anhydrous dextrose, magnesium sulfate, potassium chloride, calcium chloride, sodium phosphate |
Trademark Results [Elliotts B]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ELLIOTTS B 86281243 4687545 Live/Registered |
Lukare Medical, LLC 2014-05-14 |
 ELLIOTTS B 74620305 2101832 Dead/Cancelled |
Orphan Medical, Inc. 1995-01-11 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.