normosol-r and dextrose

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

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

Drug Facts

Product Profile

Brand Name normosol-r and dextrose
Generic Name dextrose, sodium chloride, sodium acetate anhydrous, sodium gluconate, potassium chloride, and magnesium chloride
Labeler icu medical inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

dextrose monohydrate 5 g/100mL, magnesium chloride 30 mg/100mL, potassium chloride 37 mg/100mL, sodium acetate anhydrous 222 mg/100mL, sodium chloride 526 mg/100mL, sodium gluconate 502 mg/100mL

Manufacturer
ICU Medical Inc.

Identifiers & Regulatory

Product NDC 0990-7968
Product ID 0990-7968_5a7f3e54-763c-4883-adf2-cce92ee2137b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA017609
Listing Expiration 2026-12-31
Marketing Start 2020-05-14

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 09907968
Hyphenated Format 0990-7968

Supplemental Identifiers

RxCUI
801024 1189629
UNII
LX22YL083G 02F3473H9O 660YQ98I10 NVG71ZZ7P0 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 normosol-r and dextrose (source: ndc)
Generic Name dextrose, sodium chloride, sodium acetate anhydrous, sodium gluconate, potassium chloride, and magnesium chloride (source: ndc)
Application Number NDA017609 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 5 g/100mL
  • 30 mg/100mL
  • 37 mg/100mL
  • 222 mg/100mL
  • 526 mg/100mL
  • 502 mg/100mL
source: ndc
Packaging
  • 12 BAG in 1 CASE (0990-7968-09) / 1000 mL in 1 BAG
source: ndc

Packages (1)

0990-7968-09 12 BAG in 1 CASE (0990-7968-09) / 1000 mL in 1 BAG

Ingredients (6)

dextrose monohydrate (5 g/100mL) magnesium chloride (30 mg/100mL) potassium chloride (37 mg/100mL) sodium acetate anhydrous (222 mg/100mL) sodium chloride (526 mg/100mL) sodium gluconate (502 mg/100mL)

Linked Drug Pages (1)

Normosol-R and Dextrose ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "5a7f3e54-763c-4883-adf2-cce92ee2137b", "openfda": {"unii": ["LX22YL083G", "02F3473H9O", "660YQ98I10", "NVG71ZZ7P0", "451W47IQ8X", "R6Q3791S76"], "rxcui": ["801024", "1189629"], "spl_set_id": ["ead1fca3-eff4-478f-8a8f-67510f80151a"], "manufacturer_name": ["ICU Medical Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "12 BAG in 1 CASE (0990-7968-09)  / 1000 mL in 1 BAG", "package_ndc": "0990-7968-09", "marketing_start_date": "20200514"}], "brand_name": "Normosol-R and Dextrose", "product_id": "0990-7968_5a7f3e54-763c-4883-adf2-cce92ee2137b", "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]", "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": "0990-7968", "generic_name": "Dextrose, Sodium Chloride, Sodium Acetate Anhydrous, Sodium Gluconate, Potassium Chloride, and Magnesium Chloride", "labeler_name": "ICU Medical Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Normosol-R and Dextrose", "active_ingredients": [{"name": "DEXTROSE MONOHYDRATE", "strength": "5 g/100mL"}, {"name": "MAGNESIUM CHLORIDE", "strength": "30 mg/100mL"}, {"name": "POTASSIUM CHLORIDE", "strength": "37 mg/100mL"}, {"name": "SODIUM ACETATE ANHYDROUS", "strength": "222 mg/100mL"}, {"name": "SODIUM CHLORIDE", "strength": "526 mg/100mL"}, {"name": "SODIUM GLUCONATE", "strength": "502 mg/100mL"}], "application_number": "NDA017609", "marketing_category": "NDA", "marketing_start_date": "20200514", "listing_expiration_date": "20261231"}