physiolyte

Generic: sodium chloride, sodium gluconate, sodium acetate, potassium chloride, and magnesium chloride

Labeler: b. braun medical inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name physiolyte
Generic Name sodium chloride, sodium gluconate, sodium acetate, potassium chloride, and magnesium chloride
Labeler b. braun medical inc.
Dosage Form IRRIGANT
Routes
IRRIGATION
Active Ingredients

magnesium chloride .03 g/100mL, potassium chloride .037 g/100mL, sodium acetate .37 g/100mL, sodium chloride .53 g/100mL, sodium gluconate .5 g/100mL

Manufacturer
B. Braun Medical Inc.

Identifiers & Regulatory

Product NDC 0264-2205
Product ID 0264-2205_03ced4e7-7317-45fb-8303-54a924c7d281
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA019024
Listing Expiration 2026-12-31
Marketing Start 1984-06-08

Pharmacologic Class

Classes
calculi dissolution agent [epc] increased large intestinal motility [pe] inhibition large intestine fluid/electrolyte absorption [pe] inhibition small intestine fluid/electrolyte absorption [pe] magnesium ion exchange activity [moa] osmotic activity [moa] osmotic laxative [epc] potassium compounds [cs] potassium salt [epc] stimulation large intestine fluid/electrolyte secretion [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 02642205
Hyphenated Format 0264-2205

Supplemental Identifiers

RxCUI
827351 827353
UNII
02F3473H9O 660YQ98I10 4550K0SC9B 451W47IQ8X R6Q3791S76

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name physiolyte (source: ndc)
Generic Name sodium chloride, sodium gluconate, sodium acetate, potassium chloride, and magnesium chloride (source: ndc)
Application Number NDA019024 (source: ndc)
Routes
IRRIGATION
source: ndc

Resolved Composition

Strengths
  • .03 g/100mL
  • .037 g/100mL
  • .37 g/100mL
  • .53 g/100mL
  • .5 g/100mL
source: ndc
Packaging
  • 16 CONTAINER in 1 CASE (0264-2205-00) / 1000 mL in 1 CONTAINER
source: ndc

Packages (1)

0264-2205-00 16 CONTAINER in 1 CASE (0264-2205-00) / 1000 mL in 1 CONTAINER

Ingredients (5)

magnesium chloride (.03 g/100mL) potassium chloride (.037 g/100mL) sodium acetate (.37 g/100mL) sodium chloride (.53 g/100mL) sodium gluconate (.5 g/100mL)

Linked Drug Pages (1)

Physiolyte ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["IRRIGATION"], "spl_id": "03ced4e7-7317-45fb-8303-54a924c7d281", "openfda": {"unii": ["02F3473H9O", "660YQ98I10", "4550K0SC9B", "451W47IQ8X", "R6Q3791S76"], "rxcui": ["827351", "827353"], "spl_set_id": ["19c04dcb-d6f2-4624-afd4-1c7b7ddcb85e"], "manufacturer_name": ["B. Braun Medical Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "16 CONTAINER in 1 CASE (0264-2205-00)  / 1000 mL in 1 CONTAINER", "package_ndc": "0264-2205-00", "marketing_start_date": "19840608"}], "brand_name": "Physiolyte", "product_id": "0264-2205_03ced4e7-7317-45fb-8303-54a924c7d281", "dosage_form": "IRRIGANT", "pharm_class": ["Calculi Dissolution Agent [EPC]", "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]"], "product_ndc": "0264-2205", "generic_name": "Sodium Chloride, Sodium Gluconate, Sodium Acetate, Potassium Chloride, and Magnesium Chloride", "labeler_name": "B. Braun Medical Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Physiolyte", "active_ingredients": [{"name": "MAGNESIUM CHLORIDE", "strength": ".03 g/100mL"}, {"name": "POTASSIUM CHLORIDE", "strength": ".037 g/100mL"}, {"name": "SODIUM ACETATE", "strength": ".37 g/100mL"}, {"name": "SODIUM CHLORIDE", "strength": ".53 g/100mL"}, {"name": "SODIUM GLUCONATE", "strength": ".5 g/100mL"}], "application_number": "NDA019024", "marketing_category": "NDA", "marketing_start_date": "19840608", "listing_expiration_date": "20261231"}