🇺🇸
United States · US · US:0990-7965_82c807c8-da31-4166-803f-a194b26dd1dc
NORMOSOL-M AND DEXTROSE
In shortageOrange BookUNIISPLATC C03CB
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerICU Medical Inc.
CountryUS (United States)
ATC codeC03CB
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11099079650912 POUCH in 1 CASE (0990-7965-09) / 1 BAG in 1 POUCH / 1000 mL in 1 BAG
Annotations
UNII (FDA Substance ID)
LX22YL083G
DEXTROSE MONOHYDRATE
RxCUI 1299920
Orange Book
N017610
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Dextrose Monohydrate 10% Injection
Raw payload (JSON)
{
"unii": {
"unii": "LX22YL083G",
"rxcui": "1299920",
"inchikey": "SPFMQWBKVUQXJV-BTVCFUMJSA-N",
"display_name": "DEXTROSE MONOHYDRATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"aba60c84-94d9-46d0-bdbb-25e0c4e8cc41": {
"match": "brand_token",
"title": "NORMOSOL-M AND DEXTROSE (DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, POTASSIUM ACETATE, AND MAGNESIUM ACETATE) INJECTION, SOLUTION [ICU MEDICAL INC.]",
"spl_version": "11",
"published_date": "2025-11-17"
}
},
"productid": "0990-7965_82c807c8-da31-4166-803f-a194b26dd1dc",
"productndc": "0990-7965",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "017610",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "5GM/100ML;21MG/100ML;128MG/100ML;234MG/100ML",
"product_no": "001",
"approval_date": "Approved Prior to Jan 1, 1982"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DEXTROSE MONOHYDRATE; MAGNESIUM ACETATE; POTASSIUM ACETATE; SODIUM CHLORIDE",
"shortage_reason": "Dextrose Monohydrate 10% Injection",
"shortage_status": "current",
"proprietary_name": "NORMOSOL-M AND DEXTROSE",
"active_ingred_unit": "g/100mL; mg/100mL; mg/100mL; mg/100mL",
"application_number": "NDA017610",
"marketing_category": "NDA",
"nonproprietary_name": "dextrose monohydrate, sodium chloride, potassium acetate, and magnesium acetate",
"start_marketing_date": "20210208",
"active_numerator_strength": "5; 21; 128; 234"
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