0065-1795 NDC - BSS (BALANCED SALT SOLUTION)

Drug Information

Product NDC: 0065-1795

Proprietary Name: BSS

Non Proprietary Name: balanced salt solution

Active Ingredient(s):
  • 6.4 mg/mL SODIUM CHLORIDE;
  • .75 mg/mL POTASSIUM CHLORIDE;
  • .48 mg/mL CALCIUM CHLORIDE;
  • .3 mg/mL MAGNESIUM CHLORIDE;
  • 3.9 mg/mL SODIUM ACETATE;
  • 1.7 mg/mL SODIUM CITRATE


Administration Route(s): OPHTHALMIC

Dosage Form(s): SOLUTION

Pharmacy Class(es):
  • 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];
  • 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];
  • 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]

Labeler Information

Labeler Name: Alcon Laboratories, Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: NDA020742
Marketing Category: NDA
Start Marketing Date:3/28/1969

Package Information

No. Package Code Package Description Billing Unit
10065-1795-04500 mL in 1 BAG (0065-1795-04)ML

NDC Record

Field Name Field Value Definition
PRODUCT NDC0065-1795The 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.
PRODUCT TYPE NAMEHUMAN PRESCRIPTION DRUGIndicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
PROPRIETARY NAMEBSSThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEbalanced salt solutionThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMESOLUTIONThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEOPHTHALMICThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE3/28/1969This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMENDAProduct 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 NUMBERNDA020742This 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 NAMEAlcon Laboratories, Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMESODIUM CHLORIDE; POTASSIUM CHLORIDE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; SODIUM ACETATE; SODIUM CITRATEThis is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH6.4; .75; .48; .3; 3.9; 1.7 
ACTIVE INGRED UNITmg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 
PHARM CLASSESOsmotic 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],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],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] 

Download Record

Download this NDC record in Text format: Export

Download this NDC record in Excel (CSV) format: Export

Download this NDC record in XML format: Export

This page was last updated on: 6/12/2020