Package 0990-7965-09
Brand: normosol-m and dextrose
Generic: dextrose monohydrate, sodium chloride, potassium acetate, and magnesium acetatePackage Facts
Identity
Package NDC
0990-7965-09
Digits Only
0990796509
Product NDC
0990-7965
Description
12 POUCH in 1 CASE (0990-7965-09) / 1 BAG in 1 POUCH / 1000 mL in 1 BAG
Marketing
Marketing Status
Brand
normosol-m and dextrose
Generic
dextrose monohydrate, sodium chloride, potassium acetate, and magnesium acetate
Sample Package
No
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"}