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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

  • ndc11
    0990796809
    12 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

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