NDC 0065-0795

BSS

Balanced Salt Solution

BSS is a Ophthalmic Solution in the Human Prescription Drug category. It is labeled and distributed by Alcon Laboratories, Inc.. The primary component is Calcium Chloride; Magnesium Chloride; Potassium Chloride; Sodium Acetate; Sodium Chloride; Sodium Citrate.

Product ID0065-0795_19d9e9e4-f86c-4139-8c67-e5f88c828ecf
NDC0065-0795
Product TypeHuman Prescription Drug
Proprietary NameBSS
Generic NameBalanced Salt Solution
Dosage FormSolution
Route of AdministrationOPHTHALMIC
Marketing Start Date1969-03-28
Marketing CategoryNDA / NDA
Application NumberNDA020742
Labeler NameAlcon Laboratories, Inc.
Substance NameCALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM CITRATE
Active Ingredient Strength0 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL
Pharm ClassesBlood 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], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0065-0795-15

15 mL in 1 BOTTLE (0065-0795-15)
Marketing Start Date1969-03-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0065-0795-50 [00065079550]

BSS SOLUTION
Marketing CategoryNDA
Application NumberNDA020742
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1969-03-28

NDC 0065-0795-25 [00065079525]

BSS SOLUTION
Marketing CategoryNDA
Application NumberNDA020742
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1969-03-28
Marketing End Date2016-04-06

NDC 0065-0795-15 [00065079515]

BSS SOLUTION
Marketing CategoryNDA
Application NumberNDA020742
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1969-03-28

NDC 0065-0795-30 [00065079530]

BSS SOLUTION
Marketing CategoryNDA
Application NumberNDA020742
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1969-03-28
Marketing End Date2018-12-31

Drug Details

Active Ingredients

IngredientStrength
SODIUM CHLORIDE6.4 mg/mL

OpenFDA Data

SPL SET ID:4bd4d59c-eb3b-4a5e-9eb7-ae95b0a92bea
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 806392
  • 806396
  • UPC Code
  • 0300650795159
  • Pharmacological Class

    • 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]

    NDC Crossover Matching brand name "BSS" or generic name "Balanced Salt Solution"

    NDCBrand NameGeneric Name
    0065-0795BSSbalanced salt solution
    0065-1795BSSbalanced salt solution

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