NDC 67871-007

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 Qol Medical, Llc. The primary component is Sodium Chloride; Sodium Bicarbonate; Anhydrous Dextrose; Magnesium Sulfate; Potassium Chloride; Calcium Chloride; Sodium Phosphate.

• Product ID: 67871-007_6b61a6f9-0cc7-47bf-a600-ae8bb89a9501
• NDC: 67871-007
• 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: 2006-09-27
• Marketing Category: NDA / NDA
• Application Number: NDA020577
• Labeler Name: QOL Medical, LLC
• Substance Name: SODIUM CHLORIDE; SODIUM BICARBONATE; ANHYDROUS DEXTROSE; MAGNESIUM SULFATE; 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: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 67871-007-10

10 AMPULE in 1 BOX (67871-007-10) > 10 mL in 1 AMPULE (67871-007-01)

• Marketing Start Date: 2006-09-27
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 67871-007-01 [67871000701]

Elliotts B INJECTION

• Marketing Category: NDA
• Application Number: NDA020577
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2006-09-27

NDC 67871-007-10 [67871000710]

Elliotts B INJECTION

• Marketing Category: NDA
• Application Number: NDA020577
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2006-09-27
• Inactivation Date: 2019-11-27

Drug Details

Active Ingredients

Ingredient	Strength
SODIUM CHLORIDE	73 mg/10mL

OpenFDA Data

• SPL SET ID: b1e83fb1-7f51-41b7-a1eb-495414bbf1f2
• Manufacturer:
  • QOL Medical, LLC
• UNII:
  • 8MDF5V39QO
  • M4I0D6VV5M
  • 451W47IQ8X
  • SE337SVY37
  • 5SL0G7R0OK
  • 660YQ98I10

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]

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