multiple electrolytes ph 5.5

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

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name multiple electrolytes ph 5.5
Generic Name sodium chloride, sodium gluconate, sodium acetate, potassium chloride and magnesium chloride
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

magnesium chloride 30 mg/100mL, potassium chloride 37 mg/100mL, sodium acetate 368 mg/100mL, sodium chloride 526 mg/100mL, sodium gluconate 502 mg/100mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 65219-387
Product ID 65219-387_847f9b87-ebe4-4ff7-89b7-bcee26ef1f49
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215370
Listing Expiration 2026-12-31
Marketing Start 2021-07-01

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 65219387
Hyphenated Format 65219-387

Supplemental Identifiers

RxCUI
801109
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 multiple electrolytes ph 5.5 (source: ndc)
Generic Name sodium chloride, sodium gluconate, sodium acetate, potassium chloride and magnesium chloride (source: ndc)
Application Number ANDA215370 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 30 mg/100mL
  • 37 mg/100mL
  • 368 mg/100mL
  • 526 mg/100mL
  • 502 mg/100mL
source: ndc
Packaging
  • 20 BAG in 1 CASE (65219-387-05) / 500 mL in 1 BAG (65219-387-00)
  • 10 BAG in 1 CASE (65219-387-10) / 1000 mL in 1 BAG (65219-387-02)
source: ndc

Packages (2)

65219-387-05 20 BAG in 1 CASE (65219-387-05) / 500 mL in 1 BAG (65219-387-00) 65219-387-10 10 BAG in 1 CASE (65219-387-10) / 1000 mL in 1 BAG (65219-387-02)

Ingredients (5)

magnesium chloride (30 mg/100mL) potassium chloride (37 mg/100mL) sodium acetate (368 mg/100mL) sodium chloride (526 mg/100mL) sodium gluconate (502 mg/100mL)

Linked Drug Pages (1)

Multiple Electrolytes pH 5.5 ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "847f9b87-ebe4-4ff7-89b7-bcee26ef1f49", "openfda": {"unii": ["02F3473H9O", "660YQ98I10", "4550K0SC9B", "451W47IQ8X", "R6Q3791S76"], "rxcui": ["801109"], "spl_set_id": ["cf1f5f15-d31d-4a02-8f7e-b289d5ad4b5c"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "20 BAG in 1 CASE (65219-387-05)  / 500 mL in 1 BAG (65219-387-00)", "package_ndc": "65219-387-05", "marketing_start_date": "20221021"}, {"sample": false, "description": "10 BAG in 1 CASE (65219-387-10)  / 1000 mL in 1 BAG (65219-387-02)", "package_ndc": "65219-387-10", "marketing_start_date": "20221021"}], "brand_name": "Multiple Electrolytes pH 5.5", "product_id": "65219-387_847f9b87-ebe4-4ff7-89b7-bcee26ef1f49", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Calculi Dissolution Agent [EPC]", "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 Small Intestine Fluid/Electrolyte Absorption [PE]", "Magnesium Ion Exchange Activity [MoA]", "Osmotic Activity [MoA]", "Osmotic Activity [MoA]", "Osmotic Activity [MoA]", "Osmotic Laxative [EPC]", "Osmotic Laxative [EPC]", "Osmotic Laxative [EPC]", "Potassium Compounds [CS]", "Potassium Salt [EPC]", "Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"], "product_ndc": "65219-387", "generic_name": "sodium chloride, sodium gluconate, sodium acetate, potassium chloride and magnesium chloride", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Multiple Electrolytes pH 5.5", "active_ingredients": [{"name": "MAGNESIUM CHLORIDE", "strength": "30 mg/100mL"}, {"name": "POTASSIUM CHLORIDE", "strength": "37 mg/100mL"}, {"name": "SODIUM ACETATE", "strength": "368 mg/100mL"}, {"name": "SODIUM CHLORIDE", "strength": "526 mg/100mL"}, {"name": "SODIUM GLUCONATE", "strength": "502 mg/100mL"}], "application_number": "ANDA215370", "marketing_category": "ANDA", "marketing_start_date": "20210701", "listing_expiration_date": "20261231"}