0264-1945 NDC - BALANCED SALT ()

Drug Information

  • Product NDC: 0264-1945
  • Proprietary Name: Balanced Salt
  • Non Proprietary Name:
  • Active Ingredient(s): .48 mg/mL CALCIUM CHLORIDE; .3 mg/mL MAGNESIUM CHLORIDE; .75 mg/mL POTASSIUM CHLORIDE; 3.9 mg/mL SODIUM ACETATE; 6.4 mg/mL SODIUM CHLORIDE; 1.7 mg/mL SODIUM CITRATE
  • Administration Route(s):
  • Dosage Form(s):
  • Pharmacy Class(es): Blood Coagulation Factor [EPC]; Calcium [CS]; Calculi Dissolution Agent [EPC]; Cations; Divalent [CS]; Increased Coagulation Factor Activity [PE]; Increased Large Intestinal Motility [PE]; Increased Large Intestinal Motility [PE]; Increased Large Intestinal Motility [PE]; Increased Large Intestinal Motility [PE]; Increased Large Intestinal Motility [PE]; Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]; Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]; Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]; Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]; Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]; Inhibition Small Intestine Fluid/Electrolyte Absorption [PE]; Magnesium Ion Exchange Activity [MoA]; Osmotic Activity [MoA]; Osmotic Activity [MoA]; Osmotic Activity [MoA]; Osmotic Activity [MoA]; Osmotic Activity [MoA]; Osmotic Laxative [EPC]; Osmotic Laxative [EPC]; Osmotic Laxative [EPC]; Osmotic Laxative [EPC]; Osmotic Laxative [EPC]; Phosphate Binder [EPC]; Phosphate Chelating Activity [MoA]; Potassium Compounds [CS]; Potassium Salt [EPC]; Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]

Labeler Information

Field Name Field Value
Labeler Name: B. Braun Medical Inc.
Product Type:
FDA Application Number: ANDA091387
Marketing Category: ANDA
Start Marketing Date:2/3/2010
End Marketing Date:2/22/2022

Package Information

No. Package Code Package Description Billing Unit
10264-1945-10500 mL in 1 BAG (0264-1945-10)
20264-1945-10500 mL in 1 BAG (0264-1945-10)

NDC Record

Field Name Field Value Definition
PRODUCT NDC0264-1945The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PROPRIETARY NAMEBalanced SaltThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE2/3/2010This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEANDAProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
APPLICATION NUMBERANDA091387This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMEB. Braun Medical Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
PRODUCT NDC0264-1945The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PROPRIETARY NAMEBalanced SaltThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE1/28/2022This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEANDAProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
APPLICATION NUMBERANDA091387This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMEB. Braun Medical Inc.Name of Company corresponding to the labeler code segment of the Product NDC.

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This page was last updated on: 5/26/2025

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