normosol-m and dextrose
Generic: dextrose monohydrate, sodium chloride, potassium acetate, and magnesium acetate
Labeler: icu medical inc.Drug Facts
Product Profile
Brand Name
normosol-m and dextrose
Generic Name
dextrose monohydrate, sodium chloride, potassium acetate, and magnesium acetate
Labeler
icu medical inc.
Dosage Form
INJECTION, SOLUTION
Routes
Active Ingredients
dextrose monohydrate 5 g/100mL, magnesium acetate 21 mg/100mL, potassium acetate 128 mg/100mL, sodium chloride 234 mg/100mL
Manufacturer
Identifiers & Regulatory
Product NDC
0990-7965
Product ID
0990-7965_82c807c8-da31-4166-803f-a194b26dd1dc
Product Type
HUMAN PRESCRIPTION DRUG
Marketing Category
NDA
Application Number
NDA017610
Listing Expiration
2026-12-31
Marketing Start
2021-02-08
Pharmacologic Class
Classes
Normalized Code Variants
Searchable formats for this product NDC code
Digits Only
09907965
Hyphenated Format
0990-7965
Supplemental Identifiers
RxCUI
UNII
Packaging Origin
Original Packager
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-m and dextrose (source: ndc)
Generic Name
dextrose monohydrate, sodium chloride, potassium acetate, and magnesium acetate (source: ndc)
Application Number
NDA017610 (source: ndc)
Routes
source: ndc
Resolved Composition
Strengths
- 5 g/100mL
- 21 mg/100mL
- 128 mg/100mL
- 234 mg/100mL
Packaging
- 12 POUCH in 1 CASE (0990-7965-09) / 1 BAG in 1 POUCH / 1000 mL in 1 BAG
Packages (1)
Ingredients (4)
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["INTRAVENOUS"], "spl_id": "82c807c8-da31-4166-803f-a194b26dd1dc", "openfda": {"unii": ["LX22YL083G", "0E95JZY48K", "M911911U02", "451W47IQ8X"], "rxcui": ["801005", "801009"], "spl_set_id": ["aba60c84-94d9-46d0-bdbb-25e0c4e8cc41"], "manufacturer_name": ["ICU Medical Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "12 POUCH in 1 CASE (0990-7965-09) / 1 BAG in 1 POUCH / 1000 mL in 1 BAG", "package_ndc": "0990-7965-09", "marketing_start_date": "20210208"}], "brand_name": "NORMOSOL-M AND DEXTROSE", "product_id": "0990-7965_82c807c8-da31-4166-803f-a194b26dd1dc", "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": "0990-7965", "generic_name": "dextrose monohydrate, sodium chloride, potassium acetate, and magnesium acetate", "labeler_name": "ICU Medical Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "NORMOSOL-M AND DEXTROSE", "active_ingredients": [{"name": "DEXTROSE MONOHYDRATE", "strength": "5 g/100mL"}, {"name": "MAGNESIUM ACETATE", "strength": "21 mg/100mL"}, {"name": "POTASSIUM ACETATE", "strength": "128 mg/100mL"}, {"name": "SODIUM CHLORIDE", "strength": "234 mg/100mL"}], "application_number": "NDA017610", "marketing_category": "NDA", "marketing_start_date": "20210208", "listing_expiration_date": "20261231"}