🇺🇸
United States · US · US:0990-7968_5a7f3e54-763c-4883-adf2-cce92ee2137b
Normosol-R 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
- ndc11099079680912 BAG in 1 CASE (0990-7968-09) / 1000 mL in 1 BAG
Annotations
UNII (FDA Substance ID)
LX22YL083G
DEXTROSE MONOHYDRATE
RxCUI 1299920
Orange Book
N017609
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Dextrose Monohydrate 50% 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": {
"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": "0990-7968_5a7f3e54-763c-4883-adf2-cce92ee2137b",
"productndc": "0990-7968",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "017609",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "5GM/100ML;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": "DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE ANHYDROUS; SODIUM CHLORIDE; SODIUM GLUCONATE",
"shortage_reason": "Dextrose Monohydrate 50% Injection",
"shortage_status": "current",
"proprietary_name": "Normosol-R and Dextrose",
"active_ingred_unit": "g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
"application_number": "NDA017609",
"marketing_category": "NDA",
"nonproprietary_name": "Dextrose, Sodium Chloride, Sodium Acetate Anhydrous, Sodium Gluconate, Potassium Chloride, and Magnesium Chloride",
"start_marketing_date": "20200514",
"active_numerator_strength": "5; 30; 37; 222; 526; 502"
}Related drugs
Other records sharing ATC code C03CB.
- 🇺🇸12 CELL SALTS COMPLEXSEVENE USA
- 🇺🇸3ECARE Dual FormulaToothpastefor sensitiveteethHangzhou Namei Zhikang Technology Co., Ltd.
- GBAabKCL effervescent tabletsTriOn Pharma Ltd
- GBAace K effervescent tabletsEssential-Healthcare Ltd
- 🇺🇸Acclean Anti-Cavity Sensitivity ReliefHenry Schein, Inc.
- 🇺🇸ACNEPLYMOUTH HEALTHCARE PRODUCTS LLC
- 🇺🇸Acne DropsProfessional Complementary Health Formulas
- 🇺🇸Acne ReliefNaturalCare
Access this data programmatically
Query Normosol-R and Dextrose and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.