NDC 17478-921

Balanced Salt

Sodium Chloride, Potassium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Acetate And Trisodium Citrate Dihydrate

Balanced Salt is a Ophthalmic Solution in the Human Prescription Drug category. It is labeled and distributed by Akorn, Inc.. The primary component is Sodium Chloride; Potassium Chloride; Calcium Chloride; Magnesium Chloride; Sodium Acetate; Trisodium Citrate Dihydrate.

• Product ID: 17478-921_a9922ee0-385a-4abf-8fbc-0e60702bbc48
• NDC: 17478-921
• Product Type: Human Prescription Drug
• Proprietary Name: Balanced Salt
• Generic Name: Sodium Chloride, Potassium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Acetate And Trisodium Citrate Dihydrate
• Dosage Form: Solution
• Route of Administration: OPHTHALMIC
• Marketing Start Date: 2014-11-27
• Marketing Category: ANDA / ANDA
• Application Number: ANDA075503
• Labeler Name: Akorn, Inc.
• Substance Name: SODIUM CHLORIDE; POTASSIUM CHLORIDE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; SODIUM ACETATE; TRISODIUM CITRATE DIHYDRATE
• Active Ingredient Strength: 6 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL
• Pharm Classes: 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],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],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 17478-921-95

1 BOTTLE, GLASS in 1 BOTTLE (17478-921-95) > 500 mL in 1 BOTTLE, GLASS

• Marketing Start Date: 2014-11-27
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 17478-921-95 [17478092195]

Balanced Salt SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA075503
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2014-11-27

Drug Details

Active Ingredients

Ingredient	Strength
SODIUM CHLORIDE	6.4 mg/mL

OpenFDA Data

• SPL SET ID: eee80ec9-495f-413d-b3d6-03924e9d2a02
• Manufacturer:
  • Akorn, Inc.
• UNII:
  • M4I0D6VV5M
  • 02F3473H9O
  • 4550K0SC9B
  • 451W47IQ8X
  • B22547B95K
  • 660YQ98I10
• RxNorm Concept Unique ID - RxCUI:
  • 806392
• UPC Code:
  • 0317478921950

Pharmacological Class

• 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]
• 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]
• Acidifying Activity [MoA]
• Calculi Dissolution Agent [EPC]
• Anti-coagulant [EPC]
• Decreased Coagulation Factor Activity [PE]
• Calcium Chelating 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]
• Blood Coagulation Factor [EPC]
• Increased Coagulation Factor Activity [PE]
• Calcium [CS]
• Cations
• Divalent [CS]
• 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]
• Acidifying Activity [MoA]
• Calculi Dissolution Agent [EPC]
• Anti-coagulant [EPC]
• Decreased Coagulation Factor Activity [PE]
• Calcium Chelating Activity [MoA]

NDC Crossover Matching brand name "Balanced Salt" or generic name "Sodium Chloride, Potassium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Acetate And Trisodium Citrate Dihydrate"

NDC	Brand Name	Generic Name
0264-1945	Balanced Salt	Sodium Chloride, Potassium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Acetate, and Sodium Citrate
0264-2514	Balanced Salt	Sodium Chloride, Potassium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Acetate, and Sodium Citrate
17478-920	BALANCED SALT	Calcium Chloride, Magnesium Chloride, Potassium Chloride, Sodium Acetate, Sodium Chloride, Sodium Citrate
17478-921	Balanced Salt	Sodium Chloride, Potassium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Acetate and Trisodium Citrate Dihydrate