🇺🇸
United States · US · US:0990-7967_3315ac00-862e-4bc3-af5b-b15a9894efa5
Normosol-R
Orange 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
- ndc11099079670912 POUCH in 1 CASE (0990-7967-09) / 1 BAG in 1 POUCH / 1000 mL in 1 BAG
Annotations
UNII (FDA Substance ID)
02F3473H9O
MAGNESIUM CHLORIDE
RxCUI 221118
Orange Book
N017586
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "02F3473H9O",
"rxcui": "221118",
"inchikey": "DHRRIBDTHFBPNG-UHFFFAOYSA-L",
"display_name": "MAGNESIUM CHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"ead1fca3-eff4-478f-8a8f-67510f80151a": {
"match": "brand_token",
"title": "NORMOSOL-R AND DEXTROSE (DEXTROSE, SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE) INJECTION, SOLUTION [ICU MEDICAL INC.]",
"spl_version": "13",
"published_date": "2025-11-17"
}
},
"productid": "0990-7967_3315ac00-862e-4bc3-af5b-b15a9894efa5",
"productndc": "0990-7967",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "017586",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "30MG/100ML;37MG/100ML;222MG/100ML;526MG/100ML;502MG/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": "MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE ANHYDROUS; SODIUM CHLORIDE; SODIUM GLUCONATE",
"proprietary_name": "Normosol-R",
"active_ingred_unit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
"application_number": "NDA017586",
"marketing_category": "NDA",
"nonproprietary_name": "SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE",
"start_marketing_date": "20190918",
"active_numerator_strength": "30; 37; 222; 526; 502"
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