potassium chloride in dextrose and sodium chloride

Generic: dextrose monohydrate, sodium chloride, and potassium chloride

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

Drug Facts

Product Profile

Brand Name potassium chloride in dextrose and sodium chloride
Generic Name dextrose monohydrate, sodium chloride, and potassium chloride
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

dextrose monohydrate 50 g/1000mL, potassium chloride 2.24 g/1000mL, sodium chloride 4.5 g/1000mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 65219-146
Product ID 65219-146_93737cd2-f9e0-41e1-9263-2c4ff516395a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213523
Listing Expiration 2026-12-31
Marketing Start 2022-08-26

Pharmacologic Class

Classes
increased large intestinal motility [pe] inhibition large intestine fluid/electrolyte absorption [pe] osmotic activity [moa] osmotic laxative [epc] potassium compounds [cs] potassium salt [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65219146
Hyphenated Format 65219-146

Supplemental Identifiers

RxCUI
615099 615100 630796 1863605 1863607
UNII
660YQ98I10 451W47IQ8X LX22YL083G

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 potassium chloride in dextrose and sodium chloride (source: ndc)
Generic Name dextrose monohydrate, sodium chloride, and potassium chloride (source: ndc)
Application Number ANDA213523 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 g/1000mL
  • 2.24 g/1000mL
  • 4.5 g/1000mL
source: ndc
Packaging
  • 10 BAG in 1 CASE (65219-146-10) / 1000 mL in 1 BAG (65219-146-06)
source: ndc

Packages (1)

65219-146-10 10 BAG in 1 CASE (65219-146-10) / 1000 mL in 1 BAG (65219-146-06)

Ingredients (3)

dextrose monohydrate (50 g/1000mL) potassium chloride (2.24 g/1000mL) sodium chloride (4.5 g/1000mL)

Linked Drug Pages (1)

Potassium Chloride in Dextrose and Sodium Chloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "93737cd2-f9e0-41e1-9263-2c4ff516395a", "openfda": {"unii": ["660YQ98I10", "451W47IQ8X", "LX22YL083G"], "rxcui": ["615099", "615100", "630796", "1863605", "1863607"], "spl_set_id": ["fe5b5182-c859-4c74-b2e0-467be5b2e329"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 BAG in 1 CASE (65219-146-10)  / 1000 mL in 1 BAG (65219-146-06)", "package_ndc": "65219-146-10", "marketing_start_date": "20220826"}], "brand_name": "Potassium Chloride in Dextrose and Sodium Chloride", "product_id": "65219-146_93737cd2-f9e0-41e1-9263-2c4ff516395a", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Increased Large Intestinal Motility [PE]", "Increased Large Intestinal Motility [PE]", "Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]", "Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]", "Osmotic Activity [MoA]", "Osmotic Activity [MoA]", "Osmotic Laxative [EPC]", "Osmotic Laxative [EPC]", "Potassium Compounds [CS]", "Potassium Salt [EPC]"], "product_ndc": "65219-146", "generic_name": "DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDE", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Potassium Chloride in Dextrose and Sodium Chloride", "active_ingredients": [{"name": "DEXTROSE MONOHYDRATE", "strength": "50 g/1000mL"}, {"name": "POTASSIUM CHLORIDE", "strength": "2.24 g/1000mL"}, {"name": "SODIUM CHLORIDE", "strength": "4.5 g/1000mL"}], "application_number": "ANDA213523", "marketing_category": "ANDA", "marketing_start_date": "20220826", "listing_expiration_date": "20261231"}