normosol-r

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

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 0990-7670
Product ID 0990-7670_59eb85f7-9d0b-4b22-bc56-c655f9615d8c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA017586
Listing Expiration 2026-12-31
Marketing Start 2019-09-01

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 09907670
Hyphenated Format 0990-7670

Supplemental Identifiers

RxCUI
800985 800988
UNII
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 (source: ndc)
Generic Name sodium chloride, sodium acetate anhydrous, sodium gluconate, potassium chloride, and magnesium chloride (source: ndc)
Application Number NDA017586 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 30 mg/100mL
  • 37 mg/100mL
  • 222 mg/100mL
  • 526 mg/100mL
  • 502 mg/100mL
source: ndc
Packaging
  • 24 BAG in 1 CASE (0990-7670-03) / 500 mL in 1 BAG
  • 12 BAG in 1 CASE (0990-7670-09) / 1000 mL in 1 BAG
source: ndc

Packages (2)

0990-7670-03 24 BAG in 1 CASE (0990-7670-03) / 500 mL in 1 BAG 0990-7670-09 12 BAG in 1 CASE (0990-7670-09) / 1000 mL in 1 BAG

Ingredients (5)

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 ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "59eb85f7-9d0b-4b22-bc56-c655f9615d8c", "openfda": {"unii": ["02F3473H9O", "660YQ98I10", "NVG71ZZ7P0", "451W47IQ8X", "R6Q3791S76"], "rxcui": ["800985", "800988"], "spl_set_id": ["0e089a44-0cee-4804-8f6f-8508508ddb5c"], "manufacturer_name": ["ICU Medical Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "24 BAG in 1 CASE (0990-7670-03)  / 500 mL in 1 BAG", "package_ndc": "0990-7670-03", "marketing_start_date": "20191231"}, {"sample": false, "description": "12 BAG in 1 CASE (0990-7670-09)  / 1000 mL in 1 BAG", "package_ndc": "0990-7670-09", "marketing_start_date": "20190901"}], "brand_name": "Normosol-R", "product_id": "0990-7670_59eb85f7-9d0b-4b22-bc56-c655f9615d8c", "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": "0990-7670", "generic_name": "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", "active_ingredients": [{"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": "NDA017586", "marketing_category": "NDA", "marketing_start_date": "20190901", "listing_expiration_date": "20261231"}